As a Senior Statistician at ICON, you will contribute to our biostatistics function, working collaboratively to deliver high-quality outcomes across our clinical programmes.

Responsibilities:

• Assist senior biostatisticians in clinical study support, including study design, sample size calculations, patient randomisation, data analysis, and results reporting.
• Support the statistical aspects of case report form design.
• Help in writing statistical analysis plans, defining derived data, and designing statistical tables and figures for clinical summary reports.
• Write data quality control specifications, utilise relevant computer languages and software.
• Develop and execute data manipulation and analysis programs.
• Assist in conducting statistical analyses and interpreting results.
• Prepare statistical summary reports and contribute to the statistical methods sections of integrated study reports.

Your Profile:

• Bachelor's degree in Statistics or a related field.
• Experience in a biostatistics role in the pharmaceutical, clinical research, or healthcare industry is preferred.
• RWE experience required.
• Proficiency in statistical concepts, study design, sample size calculations, and patient randomisation.
• Familiarity with statistical analysis plans and the design of statistical tables, figures, and data listings for clinical reports.
• Strong data analysis skills, including data manipulation, retrieval, and interpretation.
• Proficiency in relevant computer languages and statistical software packages.
• Ability to write and implement programs to select, retrieve, manipulate, edit, and analyse data.

Rewards & Benefits

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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As a Clinical Research Associate (CRA II) at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Responsibilities

You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include:

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports.

Your Profile

You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organisational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to travel as required (approximately 60%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Responsibilities

You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include:

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports.

Your Profile

You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organisational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to travel as required (approximately 60%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally. The person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Key Responsibilities:

• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRAs).
• Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /CRDs, other roles.
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Contributes to the development of local SOPs.
• Coordinates and liaises with CTM, CTA, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
• Collaborates closely with Headquarter to align country timelines for assigned protocols.
• Provides support and oversight to local vendors as applicable.
• Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
• Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
• Required to in/directly influence investigators, external partners and country operations to adhere to budget targets and agreed payment timelines.
• Works in partnership internally with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
• Contribute or lead initiatives and projects adding value to the business.
• Contributes strongly to the team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Contributes to the team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.

Your Profile:

• 5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
• Expertise of core clinical systems, tools and metrics.
• Excellent verbal and written influencing and training/mentoring skills, in local language and English.
• Strong coordination and organisational skills.
• Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the manager.
• Ability to make decisions independently with limited oversight from the manager.
• Requires strong understanding of local regulatory environment.
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
• Willingness to travel as required (approximately 25%).

Rewards & Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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You will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Responsibilities:

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports.

Your Profile:

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organisational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to travel as required (approximately 60%).

Rewards & Benefits:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As an Associate Project Manager at ICON, you will support the coordination and management of clinical trials, contributing to the design, analysis, and advancement of innovative treatments and therapies.

What You Will Do:

You will oversee project and programme management workstreams, ensuring deliverables meet quality and timeline expectations. Key responsibilities include:

• Assisting project managers in the planning, execution, and monitoring of clinical trials.
• Coordinating study activities, including site selection, patient recruitment, and data collection.
• Supporting the development of study protocols, case report forms, and other study-related documents.
• Participating in data analysis and interpretation to support decision-making and regulatory submissions.
• Collaborating with cross-functional teams to ensure project milestones are met and deliverables are achieved.

Your Profile:

You will have solid project and programme management experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Minimum of 2 years of experience in clinical research or project management.
• Strong organisational and multitasking skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a fast-paced and team-oriented environment.
• Willingness to travel as required (approximately 10%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

Responsibilities

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports.

Your Profile

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 3 years of experience as a Clinical Research Associate & On-Site Monitoring.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Current or Prior experience in Therapeutic Areas like Oncology or Immunology or Cardiology or Gastroenterology or Pulmonology is a Must.
• Strong organisational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license.

Rewards & Benefits

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%).

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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You will serve as the primary point of contact for site administration and logistical needs during enrollment and maintenance and Data Base Lock (DBL).

Key responsibilities include:

• Clinical Trial Execution & Site Support:
• Collaborate with PIs and study coordinators to troubleshoot technical and administrative activities and issues
• Ensure timely site support and sustained engagement through consistent communication, proactive problem-solving, and appropriate follow-up
• Track and monitor documentation and systems information to ensure compliance and quality standards are maintained
• Regulatory & Documentation Oversight:
• Support maintenance and update of the Trial Master File (TMF) with essential enrollment and maintenance documentation
• Ensure documentation of patient-related activities, deviation handling, and site correspondence aligns with GCP and internal SOPs
• Operational Efficiency & Collaboration:
• Collaborate with monitors, CRLs, and cross-functional teams to identify unique and trending needs, operational risks, and site administrative feedback
• Utilize internal tracking tools and systems to ensure real-time visibility into site status/compliance

Requirements:

• Bachelor's degree with at least 2 years of experience in clinical research
• Knowledge of Good Documentation Practices
• Systems experience (Veeva, TMF) highly preferred
• Understanding of the overall clinical development paradigm
• Must be bilingual: French/English

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

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You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Fluent German and English
• Willingness to travel as required (approximately 60%)

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Clinical QA Senior Project Manager at ICON, you will be responsible for leading and managing projects, ensuring successful execution and delivery of project objectives.

We are seeking an experienced GCP QA Senior Project Manager to drive procedural excellence, quality, compliance, and operational effectiveness across global clinical development programs.

This is a highly visible, cross-functional role for a clinical operations professional who is passionate about process improvement, inspection readiness, and developing scalable, compliant ways of working. You will partner with stakeholders across Clinical Operations, Quality, and Medical Affairs to optimize processes, lead complex initiatives, and ensure clinical trials remain inspection ready.

What You Will Do:

You will manage day-to-day project and programme management activities, supporting your team to deliver quality outcomes. Key Responsibilities:

• Lead the development, revision, implementation, and retirement of controlled documents, SOPs, work instructions, and guidance materials.
• Drive cross-functional process improvement initiatives that enhance efficiency, compliance, and operational excellence.
• Partner with Quality Assurance and Clinical Operations teams to support inspection readiness and regulatory inspection activities.
• Lead quality event investigations, root cause analyses, CAPA development, and effectiveness checks.
• Manage complex projects involving multiple stakeholders and ensure timely delivery of business objectives.
• Facilitate stakeholder alignment and influence process changes across global teams.
• Develop and deliver training, onboarding, and learning initiatives to support employee capability and compliance.
• Monitor process performance, identify improvement opportunities, and report progress to senior leadership.
• Mentor colleagues and serve as a subject matter expert in procedural excellence and clinical quality.

What We're Looking For:

• Bachelor's degree in Life Sciences, Clinical Research, Healthcare, or a related field.
• 7+ years of experience within the biopharmaceutical, biotechnology, CRO, or clinical research industry.
• Strong clinical operations, quality, compliance, or process excellence background.
• Deep understanding of GCP, ICH guidelines, and global clinical trial conduct.
• Demonstrated experience leading cross-functional projects and process improvement initiatives.
• Experience authoring and managing SOPs, procedures, work instructions, or other controlled documents.
• Excellent project management, communication, facilitation, and stakeholder management skills.
• Strong written and verbal English communication skills.

Preferred Experience:

• Sponsor-side clinical research experience.
• Inspection readiness, audit support, or regulatory inspection experience.
• Quality systems, CAPA management, and deviation investigation experience.
• Experience with Veeva QMS, LMS platforms, or clinical development systems.

Rewards & Benefits: ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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You will lead country selection strategy, developing data-driven recommendations on country mix, site allocation, and enrollment distribution.

Key responsibilities include:

• Overseeing CRO completion of design and execution of feasibility assessments
• Pressure-testing enrollment assumptions
• Building and maintaining a curated site and investigator landscape
• Leading site identification and qualification
• Tracking and managing site performance history
• Maintaining feasibility metrics and enrollment
• Presenting feasibility findings, trade-offs, and recommendations
• Serving as the feasibility point of contact for assigned programs
• Managing feasibility and site intelligence vendors and CRO feasibility teams

Requirements:

• Bachelor's degree in life sciences, nursing, public health, or a related field
• 5+ years of clinical operations experience in biotech, pharma, or CRO
• Therapeutic experience in Immunology highly preferred
• Demonstrated ownership of country selection and/or site selection recommendations for global studies
• Strong quantitative skills
• Working knowledge of ICH GCP, global regulatory and start-up requirements
• Excellent written and verbal communication skills

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

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You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• At least 2 years of experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Experience in Oncology studies is strongly preferred
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Manager, Clinical Operations at ICON, you will oversee the execution of clinical trials, ensuring that they are conducted efficiently, on time, and in compliance with regulatory requirements.

What You Will Do:

Your focus will be on coordinating clinical operations delivery, resolving issues, and developing team capability. Key responsibilities include:

• Leading the operational planning and execution of clinical trials, ensuring adherence to protocols and timelines.
• Engaging with cross-functional teams to optimize trial design and enhance operational efficiency throughout the clinical development process.
• Monitoring trial progress and performance metrics, providing insights to inform decision-making and drive continuous improvement.
• Mentoring and developing junior staff, fostering a culture of collaboration and excellence within the team.
• Building strong relationships with internal and external stakeholders to facilitate smooth communication across clinical operations.

Your Profile:

You will have solid clinical operations experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience in managing clinical operations, with a solid understanding of regulatory requirements and industry standards.
• Strong leadership skills with the ability to motivate and manage teams effectively in a dynamic environment.
• Proficiency in project management tools and methodologies, with a keen focus on optimizing processes.
• Excellent communication and interpersonal skills, with a proven ability to influence stakeholders and drive successful outcomes.
• Willingness to travel as required (approximately 30%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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Key responsibilities include:

• Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy and clarity.
• Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data and summarize scientific findings.
• Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives.
• Contributing to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences.
• Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles.

You will have a strong foundation in medical writing, with experience working independently and guiding others. Required qualifications and experience include:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills.
• Strong understanding of regulatory requirements governing the preparation and submission of clinical documents and publications.
• Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams and build relationships with key stakeholders.

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development, and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Trial Master File (TMF) Specialist III at ICON, you will participate in client services contracts and internal business needs by managing Trial Master File (TMF) documentation.

Responsibilities

You will take responsibility for trial master file management deliverables, applying your skills to ensure quality and efficiency. Key responsibilities include:

• Manage Trial Master File (TMF) documentation in accordance with client requirements and ICON procedures
• Ensure the completeness, accuracy, and timeliness of TMF documentation throughout the lifecycle of clinical trials
• Partnership with cross-functional teams to collect, review, and maintain essential documents for regulatory submissions
• Conduct quality checks and audits of TMF documents to ensure compliance with regulatory standards and sponsor requirements
• Provide efforts and guidance to internal and external stakeholders on TMF-related matters

Your Profile

You will bring relevant trial master file management experience, along with the following qualifications and skills. Required qualifications and experience:

• A minimum of 3 years of experience in clinical research or document management within the pharmaceutical, biotechnology, or CRO industry
• Bachelor's degree in life sciences, documentation management, or a related discipline
• Strong attention to detail and organisational skills, with the ability to manage multiple tasks simultaneously
• Excellent communication skills, with the ability to partnership effectively with cross-functional teams
• Willingness to travel as required (approximately 5%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As a Senior Study Start Up Associate at ICON, you will be working within a large-scale, fast-paced environment, supporting the Study Start Up Team Lead in developing and executing the plan for country and site distribution in the Netherlands.

You will lead on site start-up and activation tasks requiring technical depth, with a focus on quality and continuous improvement.

Key responsibilities include:

• Efficiently driving study initiation: conducting feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
• Empowering success through specialised SSU expertise: providing expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.
• Ensuring regulatory compliance: preparing and coordinating submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
• Safeguarding patient welfare: contributing to the development, finalisation, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

You will have a strong foundation in site start-up and activation, with experience to work independently and guide others.

Required qualifications and experience:

• A Bachelor's degree or local equivalent and/or appropriate experience from a medical/science background and/or discipline.
• At least 3 years of experience or understanding of clinical study start-up requirements and activities, showing expertise in the field.
• Fluency in the local language and English is essential, enabling effective communication and collaboration with international teams.
• Willingness to travel as required (approximately 5%).

ICON offers a competitive and comprehensive total rewards package designed to support health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include:

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports.

You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills:

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organisational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to travel as required (approximately 60%).

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Trial Delivery Lead at ICON, you will lead and manage complex projects and programs across various departments, ensuring they are delivered on time, within scope, and within budget.

What You Will Do:

You will oversee site resourcing and workforce planning workstreams, ensuring deliverables meet quality and timeline expectations. Key responsibilities include:

• Leading the planning, execution, and delivery of complex programs, ensuring alignment with business objectives and strategic priorities.
• Coordinating cross-functional teams, including project managers, technical leads, and other stakeholders, to ensure seamless execution of program activities.
• Developing and managing program plans, timelines, budgets, and resources, monitoring progress and addressing any issues that may impact program success.
• Communicating program status, risks, and issues to stakeholders, providing regular updates and ensuring transparency throughout the program lifecycle.
• Identifying opportunities for process improvements and implementing best practices to enhance program efficiency, quality, and outcomes.

Your Profile:

You will have solid site resourcing and workforce planning experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

• Bachelor's degree in business, project management, engineering, or a related field. A PMP or equivalent certification is a plus. Extensive experience in program management, with a proven track record of successfully delivering large-scale projects.
• Strong leadership and team management skills, with the ability to motivate and guide cross-functional teams in a matrix environment.
• Excellent organisational and problem-solving skills, with the ability to manage multiple projects and prioritise tasks effectively.
• Proficiency in project management tools and methodologies, with experience in risk management, budgeting, and resource allocation.
• Exceptional communication and interpersonal skills, with the ability to build relationships and influence stakeholders at all levels of the organisation.
• Willingness to travel as required (approximately 25%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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You will work in close partnership with the Clinical Research Manager (CRM) and broader study team, facilitating risk-focused discussions and driving clear, practical mitigation strategies.

Key Responsibilities

• Lead and maintain study-level risk assessments for assigned sponsor studies
• Facilitate and chair cross-functional risk review meetings, ensuring focus on critical data and processes
• Drive proactive identification, discussion, and documentation of study risks
• Partner closely with the CRM and study team to ensure aligned oversight and follow-through on mitigation actions
• Review centralized monitoring outputs, KRIs, KPIs, and trends to detect emerging or systemic risks
• Support issue escalation, root cause analysis, and risk mitigation planning
• Ensure risk-based activities align with set principles and sponsor expectations
• Contribute to inspection readiness through clear documentation and defensible oversight decisions

What You Bring

• Experience in clinical trial operations, study management, monitoring, or centralized oversight
• Solid understanding of risk-based monitoring and study management principles
• Knowledge of ICH-GCP, regulatory standards, and quality frameworks
• Strong facilitation skills with confidence leading cross-functional discussions
• Analytical mindset with the ability to interpret data, trends, and signals
• Excellent communication and stakeholder management skills
• Ability to operate independently while collaborating effectively with sponsor and ICON team

Rewards & Benefits

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Clinical Research Associate at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include:

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports.

Your Profile:

You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organisational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to travel as required (approximately 60%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Benefits may vary depending on role and location.

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As a Clinical Trial Associate at ICON, you will assist with the design and analysis of clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Responsibilities

Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders. Key responsibilities include:

• Assist in the coordination and administration of clinical trials, ensuring compliance with protocols and regulatory requirements.
• Maintain and organize clinical trial documentation, including study files, essential documents, and regulatory submissions.
• Support the preparation of study-related materials, such as informed consent forms and case report forms.
• Work with cross-functional teams to facilitate communication and ensure smooth trial execution.
• Contribute to the tracking and reporting of clinical trial metrics and milestones.

Your Profile

You will bring relevant clinical research experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in a scientific or healthcare-related field.
• Prior experience or strong interest in clinical research.
• Knowledge of clinical trial processes, regulations, and guidelines.
• Excellent organisational and communication skills.
• Ability to work collaboratively in a fast-paced environment with attention to detail.
• Willingness to travel as required (approximately 10%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Prior experience in on-site monitoring of oncology trials is required.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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The Pediatric Site Engagement Specialist (Europe) will support the CGRP Pediatric Migraine Program by accelerating site identification, site activation, investigator engagement, recruitment, and enrollment across European clinical trial sites.

This is a highly field-based position requiring extensive engagement with investigators and research sites throughout Europe, with a minimum of 50% travel expected.

The successful candidate will leverage existing relationships with children's hospitals, pediatric neurology centers, pediatric headache programs, and pediatric research institutions to identify high-potential study sites, strengthen investigator engagement, and improve study execution.

Key Responsibilities:

• Identify and evaluate new pediatric migraine study sites across Europe.
• Build and maintain relationships with pediatric investigators, children's hospitals, pediatric headache centers, and study site personnel.
• Support site feasibility, startup, activation, and enrollment activities.
• Identify and address barriers to recruitment, enrollment, and participant retention.
• Support rescue activities for underperforming sites.
• Gather investigator feedback and site intelligence to inform study execution and recruitment strategy.
• Partner with study teams to prioritize opportunities and mitigate enrollment risks.
• Conduct frequent in-person site visits and investigator engagements throughout Europe.

Your Profile:

• Bachelor's degree in Life Sciences (MD/PharmD preferred)
• Minimum 10 years of relevant clinical research experience
• Demonstrated experience supporting pediatric clinical trials, pediatric research sites, or pediatric investigator networks.
• Experience working directly with investigators and clinical trial sites.
• Experience supporting site identification, feasibility, startup, recruitment, and enrollment activities.
• Established relationships with children's hospitals, pediatric neurology programs, pediatric headache centers, or pediatric research institutions across Europe.

Rewards & Benefits

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Principal Statistical Programmer at ICON, you will be responsible for leading the design and implementation of statistical programming solutions that support clinical trials and regulatory submissions.

What You Will Do:

You will manage day-to-day statistical programming activities, supporting your team to deliver quality outcomes. Key responsibilities include:

• Leading the development and validation of statistical programs for data analysis and reporting, ensuring compliance with regulatory standards.
• Collaborating with biostatisticians and clinical teams to define project requirements and ensure alignment with study objectives.
• Overseeing the creation of programming specifications, documentation, and technical reports for regulatory submissions.
• Providing mentorship and guidance to junior statistical programmers, fostering a culture of learning and continuous improvement.
• Staying current with industry trends and advancements in statistical programming to drive innovation and enhance project outcomes.

Your Profile:

You will have solid statistical programming experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

• Bachelor's degree in statistics, computer science, mathematics, or a related discipline
• Significant experience in statistical programming, particularly in the context of clinical trials and regulatory submissions.
• Expertise in programming languages such as SAS, R, or Python, with proficiency in data management and statistical analysis.
• Excellent problem-solving skills and attention to detail, with a commitment to delivering high-quality results.
• Strong communication and interpersonal skills, facilitating effective collaboration across teams and with stakeholders.
• A commitment to maintaining high standards of quality and compliance in all programming activities.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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As a Graduate Pharmacovigilance Associate at ICON, you will support the safety monitoring and reporting of pharmaceutical products.

Responsibilities

You will take responsibility for pharmacovigilance and drug safety deliverables, applying your skills to ensure quality and efficiency. Key responsibilities include:

• Supporting the collection, review, and processing of adverse event data in accordance with pharmacovigilance regulations and company procedures.
• Assisting in the preparation and submission of safety reports to regulatory authorities and stakeholders.
• Collaborating with cross-functional teams to ensure timely and accurate communication of safety information.
• Contributing to the development and maintenance of pharmacovigilance documentation, including standard operating procedures and safety management plans.
• Participating in training and development activities to gain a deeper understanding of pharmacovigilance practices and regulatory requirements.

Your Profile

You will bring relevant pharmacovigilance and drug safety experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in pharmacy, life sciences, or a related field.
• Strong attention to detail and organisational skills, with the ability to manage multiple tasks and prioritise effectively.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Basic understanding of pharmacovigilance principles and regulatory guidelines is desirable but not required; relevant training will be provided.
• Proficiency in Microsoft Office applications, with good analytical and problem-solving skills.
• Willingness to travel as required (approximately 10%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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You will oversee scientific operations workstreams, ensuring deliverables meet quality and timeline expectations. Key responsibilities include:

• Managing site engagement efforts to ensure strong relationships and clear communication between clinical trial sites and ICON teams.
• Leading and mentoring a team of site engagement professionals to support sites through the study initiation, conduct, and closeout phases.
• Collaborating with internal teams, including clinical operations and project management, to align site engagement strategies with overall study goals.
• Identifying and addressing site concerns, providing solutions to enhance site performance and overall trial success.
• Driving initiatives to improve site satisfaction and retention, ensuring efficient and effective site operations.
• Ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements, maintaining high standards in site engagement activities.

You will have solid scientific operations experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

• Bachelor's degree in life sciences, business management, or a related field, with significant experience in site engagement or clinical operations.
• Proven experience managing site relationships and engagement in a clinical trial setting, with strong knowledge of regulatory and operational requirements.
• Strong leadership and team management skills, with the ability to guide and develop a team of site engagement professionals.
• Excellent communication and problem-solving abilities, with experience in addressing site concerns and implementing solutions.
• Strong organisational and project management skills, with the ability to manage multiple sites and maintain clear communication.
• Detail-oriented and proactive, with a commitment to maintaining high standards of site satisfaction and regulatory compliance.

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As a Clinical Research Associate II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Responsibilities

You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include:

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports.

Your Profile

You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organisational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to travel as required (approximately 60%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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As a Regulatory Submission Manager at ICON, you will contribute to drug development as part of the Regulatory Affairs team.

This position serves as the regional regulatory representative within study teams, responsible for leading operational submissions execution for designated CTAs.

This role requires essential experience within CTIS and VEEVA submissions.

Responsibilities

• Drive global submission management strategy and activities for assigned protocols. Partner with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development
• Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
• Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines
• Liaise with Sponsor Core team, SSU and Study Management, regarding essential core documents and local documentation as needed from relevant supplier lines across both HA and EC submission and translation processes
• Prepare, review and support Sponsor submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct
• Responsible for the co-ordination of translations for core documents required for submission
• Manage the compilation for core package build, contributing to CTA and authoring documentation as required
• May be responsible for proactive processing of incoming request for information (RFIs) by daily monitoring RFI-dedicated mailbox and Clinical Trials Information System (CTIS) portal and reporting RFIs to study teams, ensuring effective communication and coordination to facilitate the smooth execution of regulatory submissions.
• May be responsible for proactive processing of payments, ensuring timely and accurate financial transactions involved in regulatory submissions.
• May act as local country liaison when required
• Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities
• Discuss with relevant Sponsor SMEs the interpretation of dossier requirements

Your Profile

• Extensive experience with CTIS for document uploads and/or Veeva is required
• B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
• In-depth understanding and proven execution of CTA and Central Ethics processes
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

What You Will Do:

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile:

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

What You Will Do:

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile:

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As a Project Manager, Laboratory at ICON, you will design and analyze clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Responsibilities

Your focus will be on coordinating project and programme management delivery, resolving issues, and developing team capability. Key responsibilities include:

• Ensure client satisfaction by acting as the Sponsor's main contact person in all matters regarding ICON services including the day-to-day management of studies.
• Attend and represent ICON at Sponsor meetings.
• Manage 10-15 studies in accordance with Good Clinical Practice.
• Communicate with Sponsor's study progress in a responsible and professional manner and provide Sponsors with regular management reports.
• Provide ICOLAB support to sponsor personnel.

Your Profile

You will have solid project and programme management experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

• Bachelor's degree in a relevant field such as life sciences or healthcare.
• Previous experience in project management within a laboratory or clinical research setting.
• Strong communication and interpersonal skills, with the ability to represent the company at sponsor meetings.
• Ability to manage multiple studies concurrently while ensuring adherence to regulatory standards and guidelines.
• Detail-oriented with strong organisational skills to effectively manage study documentation and timelines.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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You will serve as the primary point of contact between investigational sites and the sponsor, conducting site visits, ensuring site compliance, and maintaining up-to-date documentation.

Responsibilities:

• Serve as primary point of contact between investigational sites and the sponsor
• Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain up-to-date documentation in CTMS and eTMF systems
• Support and track site staff training and maintain compliance records
• Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
• Support subject recruitment and retention efforts at the site level
• Oversee drug accountability and ensure proper storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and escalate risks or issues to the clinical team
• Assist in tracking site budgets and ensuring timely site payments
• Collaborate with cross-functional partners

Requirements:

• Graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
• Eligible to work in United States without visa sponsorship
• Clinical research professional with 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
• Experienced monitoring Oncology and/or Hematology oncology trials
• Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
• Clear communicator, problem-solver, and collaborative team player
• Willing and able to travel up to 50% for on-site monitoring visits across southeast region

Rewards & Benefits:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental, and vision coverage
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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You will serve as the primary point of contact between investigational sites and the sponsor, conducting site visits, ensuring site compliance, and maintaining up-to-date documentation.

Responsibilities:

• Serve as primary point of contact between investigational sites and sponsor
• Conduct site visits, including selection, initiation, routine monitoring, and close-out
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain up-to-date documentation in CTMS and eTMF systems
• Support and track site staff training and maintain compliance records
• Monitor patient safety and report adverse events
• Support subject recruitment and retention efforts
• Oversee drug accountability and ensure proper storage and return
• Resolve data queries and drive timely data entry
• Document site progress and escalate risks or issues
• Assist in tracking site budgets and ensuring timely site payments
• Collaborate with cross-functional partners

Requirements:

• Graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
• Eligible to work in United States without visa sponsorship
• 2+ years of on-site monitoring experience in pharmaceutical or CRO industry
• Experience monitoring Oncology and/or Hematology oncology
• Proficient in ICH-GCP, local regulatory requirements, and clinical systems
• Clear communicator, problem-solver, and collaborative team player
• Willing and able to travel up to 50% for on-site monitoring visits

Rewards & Benefits:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental, and vision coverage
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities

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You will serve as the primary point of contact between investigational sites and the sponsor - Oncology, conducting site visits, ensuring site compliance, and maintaining up-to-date documentation.

Responsibilities:

• Serve as primary point of contact between investigational sites and the sponsor - Oncology
• Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain up-to-date documentation in CTMS and eTMF systems
• Support and track site staff training and maintain compliance records
• Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
• Support subject recruitment and retention efforts at the site level
• Oversee drug accountability and ensure proper storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and escalate risks or issues to the clinical team
• Assist in tracking site budgets and ensuring timely site payments
• Collaborate with cross-functional partners

Requirements:

• Graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
• Eligible to work in United States without visa sponsorship
• Clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
• Experienced monitoring oncology clinical trials
• Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
• Clear communicator, problem-solver, and collaborative team player
• Willing and able to travel up to 50% for on-site monitoring visits across Midwest region

Rewards & Benefits:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental, and vision coverage
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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You will be responsible for:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

To be considered, you will need:

• An advanced degree in a relevant field such as life sciences, nursing, or medicine.
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Oncology monitoring experience is required.
• Ability to travel at least 60% of the time (international and domestic) and possess a valid driver's license.

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development, which may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As a Senior Clinical Data Coordinator at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Responsibilities

You will lead on clinical research tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Create and maintain detailed data management plans and documentation, ensuring compliance with industry standards and regulatory requirements.
• Participate in the identification and resolution of data discrepancies and issues, working to streamline data flow and enhance data quality throughout the study lifecycle.
• Collaborate closely with cross-functional teams, including clinical operations and biostatistics, to develop and execute data management strategies tailored to specific studies.
• Perform other project activities as required in order to ensure that study timelines are met.
• Mentor junior data coordinators, providing expert guidance on data reconciliation, coding, and cleaning procedures.

Your Profile

You will have a strong foundation in clinical research, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant field, such as Life Sciences or Healthcare.
• Proven experience in clinical data management within the pharmaceutical or biotechnology industry.
• Familiarity with data management software and systems.
• Strong attention to detail and the ability to work effectively in a fast-paced environment.
• Excellent communication skills and the ability to collaborate with cross-functional teams.
• Knowledge of regulatory guidelines and standards is a plus.
• Willingness to travel as required.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities.

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What You Will Do: Key responsibilities include:

• Working in a home-based Client Dedicated program for Sr. investigator pricing analyst role
• Providing specialized support and assistance to the Clinical Business Operations department within the Clinical Site Payments function
• Collaborating closely with investigative sites, the Clinical Operations team, the Clinical Site Contracts Management team, the Budget Development team, and site payment vendors
• Ensuring accurate and timely site payments, along with effective management of the study portfolio through planning, execution, and tracking of global clinical trial payments

Your Profile: You will have a strong foundation in contract management, with the experience to work independently and guide others. Required qualifications and experience:

• Investigator payment experience or CTAs/CRAs with payment experience
• Bachelor's degree
• Business English communication skills
• Strong attention to detail, organisational skills, and the ability to manage multiple priorities in a fast-paced environment

Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As a Senior Project Manager at ICON, you will be responsible for leading and managing projects, ensuring successful execution and delivery of project objectives.

What You Will Do:

You will manage day-to-day project and programme management activities, supporting your team to deliver quality outcomes. Key responsibilities include:

• Developing and executing project plans, focusing on achieving project goals and objectives.
• Leading cross-functional teams to ensure the successful implementation of project activities.
• Collaborating with stakeholders to identify project requirements and define project scope.
• Mentoring and guiding team members, fostering a culture of excellence and continuous improvement.
• Driving the development of project documentation and reports to present findings to stakeholders in a clear and actionable manner.
• Staying abreast of industry trends and emerging technologies to integrate best practices into project management strategies.
• Contributing to organisational growth through effective project leadership and strategic planning.

Your Profile:

You will have solid project and programme management experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience in project management, with a proven track record of leading successful projects in the pharmaceutical or biotech industry.
• Strong proficiency in project management tools and methodologies, with excellent attention to detail.
• Excellent analytical and problem-solving skills, with the ability to develop effective project strategies.
• Demonstrated leadership skills, with experience in managing and mentoring teams effectively.
• Exceptional communication skills, with the ability to convey technical concepts to diverse audiences.
• Detail-oriented, with strong organisational skills to manage multiple projects and deadlines in a dynamic environment.
• Willingness to travel as required (approximately 25%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

The Site Activation Manager is a sponsor-dedicated role delivered through a partnership with ICON and responsible for United States study start-up and amendment activities. The role builds strong relationships with investigative sites, drives essential document collection and quality review, supports country and site ICF development and negotiation, ensures IRB submission readiness and approval follow-up, manages amendment implementation, and partners cross-functionally to achieve timely site activation and amendment implementation.

Responsibilities

Your focus will be on coordinating site start-up and activation delivery, resolving issues, and developing team capability. Key responsibilities include:

• Build strong working relationships with investigative sites and support a positive sponsor-site experience throughout start-up.
• Collect, review, QC, and file essential documents required for submission and activation.
• Review and negotiate ICF changes with sites and stakeholders; manage translations, checklists, filing, and amendment updates as required.
• Ensure IRB submissions are made and approval documentation is complete and activation-ready.
• Support regulatory and clinical trial start-up activities across the US, including coordination of submission, approval, and study activation workflows.
• Collaborate with sites and internal stakeholders to set and achieve Regulatory Greenlight (RGL) goals that support timely site activation.
• Escalate risks, manage timelines, and maintain accurate documentation and tracking in systems such as CTMS and the eTMF.
• Manage protocol amendments and related submissions, approvals, site communications, and implementation activities.

Your Profile

You will have solid site start-up and activation experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

• Clinical trial start-up experience in a site-facing or dedicated site role.
• Solid understanding of ICH GCP, applicable ethics committee requirements (IRB), and regulatory submission processes across the United States.
• Experience with essential document collection, QC, and filing.
• Experience with ICF review, negotiation, and amendment management.
• Strong cross-functional collaboration and stakeholder management skills within a sponsor-partner operating model involving ICON.
• Excellent written and spoken English, with strong organisation, judgment, and stakeholder-management skills.
• Experience with clinical trial management, electronic trial master file, or comparable research systems.
• Ability to work independently across North American time zones.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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Key responsibilities include:

• Forming, overseeing, and leading the operational sub-team and requesting resources as needed
• Developing realistic detailed study start-up and/or study management strategy and monitoring plans
• Ensuring country-level feasibility is completed in collaboration with cross-functional colleagues
• Setting up PTMF for study management and country/site-level documents
• Providing input into the IQMP risk planning process for the study
• Coordinating development of study/protocol training and global investigator meetings
• Approving and overseeing drug supply management
• Leading inspection readiness activities related to study management and site readiness
• Supporting development and delivery of decentralized capabilities at investigator sites
• Ensuring timely study closure and release of internal and external resources

Requirements:

• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
• 7+ years of relevant experience (BA/BS) or 6+ years of relevant experience (MBA/MS)
• Demonstrated clinical research experience and/or study management experience
• Demonstrated study management/leadership experience
• Demonstrated oversight of CROs/vendors

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are currently seeking a Medical Writer II to join our diverse and dynamic team. As a Medical Writer II at ICON, you will play a pivotal role in the development and preparation of clinical trial documents, regulatory submissions, and scientific publications, contributing to the advancement of innovative treatments and therapies.

Responsibilities

• Collaborating with cross-functional teams to prepare, write, and edit clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), patient narratives, and other regulatory documents in compliance with internal standards and regulatory guidelines.
• Conducting literature reviews, data analysis, and interpretation of clinical trial results to support the development of scientific manuscripts, abstracts, posters, and presentations for publication in peer-reviewed journals and scientific conferences.
• Assisting in the review and validation of clinical data, ensuring accuracy, completeness, and consistency with study protocols, standard operating procedures (SOPs), and regulatory requirements.
• Participating in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, and deliverables, while providing input and feedback on document content, format, and presentation.
• Keeping abreast of emerging trends, scientific developments, and regulatory updates in relevant therapeutic areas, and applying knowledge of medical writing principles and best practices to support the successful execution of clinical research projects.

Your Profile

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organisation (CRO) industry.
• Proficiency in scientific and medical terminology, with excellent written and verbal communication skills, attention to detail, and the ability to convey complex information in a clear and concise manner.
• Strong analytical and critical thinking skills, with the ability to review and interpret clinical data, identify key findings and trends, and communicate results effectively to diverse stakeholders.
• Familiarity with regulatory requirements, industry guidelines, and publication standards governing the preparation and submission of clinical trial documents and scientific manuscripts.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with document management systems, reference management software, and statistical analysis tools preferred.

Rewards & Benefits

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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Key responsibilities include:

• Providing strategic medical leadership and guidance on project teams.
• Offering expert medical and scientific consultation throughout project lifecycles.
• Ensuring compliance with ethical, legal, and regulatory standards in medical and safety monitoring activities.
• Representing the Medical Affairs Department in business development initiatives.
• Providing operational oversight within the Medical Affairs Department as needed.

You will bring significant medical affairs experience, with a track record of building high-performing teams and delivering results. Required qualifications and experience:

• Medical degree (MD or equivalent) with specialization in relevant therapeutic area preferred.
• Proven track record of medical leadership and consultation within pharmaceutical or biotechnology industries.
• Strong understanding of regulatory requirements and ethical standards in clinical research.
• Excellent communication and interpersonal skills, with the ability to represent the department effectively.
• Demonstrated ability to provide operational management in the absence of senior management.
• Willingness to travel as required (approximately 10%).

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include:

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports

Your Profile:

You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organisational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As a Study Start-Up CRA II at ICON Plc, you will oversee and manage site start-up and activation activities to ensure clinical trials are initiated efficiently and in compliance with protocol requirements, local regulations, and industry standards.

What You Will Do:

You will lead study start-up activities requiring technical expertise in site activation, regulatory submissions, and clinical trial operations, with a focus on quality, compliance, and timely delivery.

Key responsibilities include:

• Managing site start-up and activation activities to ensure sites are activated according to study timelines and sponsor expectations.
• Preparing, reviewing, and coordinating submissions to Ethics Committees and regulatory authorities in accordance with local requirements and ICH-GCP guidelines.
• Ensuring compliance with current local regulations, including recent COFEPRIS updates and requirements impacting clinical trial start-up in Mexico.
• Collaborating with investigative sites to collect, review, and maintain essential regulatory documentation required for site activation.
• Working closely with cross-functional teams to identify and resolve start-up challenges and ensure successful study delivery.
• Leveraging prior site monitoring experience to assess site readiness and proactively identify operational risks.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth study start-up activities.

Your Profile:

You will have a strong foundation in Study Start-Up and Site Activation activities, combined with previous CRA monitoring experience and a thorough understanding of the Mexican regulatory environment.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Strong experience in Study Start-Up and Site Activation activities within a CRO, sponsor, or clinical research organization.
• Previous Clinical Research Associate (CRA) monitoring experience, with a solid understanding of site management and clinical trial conduct.
• Strong knowledge of ICH-GCP, Ethics Committee processes, essential document management, and clinical trial start-up requirements.
• Up-to-date understanding of COFEPRIS regulations and recent regulatory changes impacting clinical trial submissions and site activation in Mexico.
• Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
• Experience working with clinical trial systems, including CTMS and eTMF platforms.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to collaborate effectively within global cross-functional teams.
• Based in Mexico City, Mexico.
• Willingness to travel as required (approximately 25%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Responsibilities

You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include:

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports.

Your Profile

You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organisational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to travel as required (approximately 60%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Benefits may vary depending on role and location.

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You will be responsible for overseeing vendors, developing strong relationships with sites, and ensuring continuity of relationships throughout the trial phases.

Key responsibilities include:

• Vendor oversight for adherence to budget, timelines, and organisational objectives
• Developing strong vendor and site relationships
• Obtaining and maintaining in-depth understanding of the study protocol and related procedures
• Coordinating and managing tasks to achieve site readiness
• Performing timely review of monitoring reports from CRO and associated deliverables
• Reviewing CRO eTMF/TMF to ensure adherence with standards and compliance with regulations
• Working with vendors to revise scope of service agreements, budgets, plans, and detailed timelines
• Supporting financial management of the study, including review and approval of site and vendor invoices
• Supporting risk management initiatives and audit/inspection activities
• Maintaining clinical trial registry entry/updates
• Providing mentorship/guidance to junior team members or cross-functional colleagues

Requirements:

• Undergraduate degree or its international equivalent in a clinical, science, or health-related field
• 5 years of relevant experience, including 3 years of experience in clinical trial management
• Fluent English and fluent in the language of the host country
• Hybrid role - office-based three days per week in Warren, NJ, Armonk, NY, or Cambridge, MA

ICON offers a competitive and comprehensive total rewards package, including:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental, and vision coverage
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities

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As a Clinical Project Manager at ICON, you will be responsible for leading and coordinating project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards.

Responsibilities

Your focus will be on coordinating project and program management delivery, resolving issues, and developing team capability in a sponsor-dedicated model environment. Key responsibilities include:

• Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery.
• Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration.
• Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track.
• Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organisational objectives.
• Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders.

Requirements

You will have solid project and clinical project management experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

• A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organisation.
• Bachelor's degree in health, life sciences, or other relevant fields of study.
• At least 10+ years of relevant experience in clinical trial management.
• Preferred: 2+ years of monitoring experience.
• Experience in managing complex or global trials is advantageous.
• Preferred: Experience in managing all trial components from start-up to database lock.
• Strong performer / executor of operational tasks with strong skills and experience in study delivery.
• Experience of working across multiple types of study designs.
• Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives.
• Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives.
• Fluency in English (reading, writing, speaking).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Benefits may vary depending on role and location.

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As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

The Project Manager (HCI Program & Operations Specialist) will serve as the operational backbone for the HCI portfolios, partnering closely with HCI Leads to plan, coordinate, execute and track multiple concurrent HCI initiatives.

Responsibilities:

• Partner with assigned HCI Leads to build and maintain integrated project plans, timelines, milestones, and budgets across a portfolio of concurrent HCIs
• Translate HCI strategy into structured workplans; track deliverables, dependencies, risks, opportunities and issues, and proactively flag items that need the HCI Lead's attention or execute within guardrails
• Maintain regular touchpoints with external collaborators as the projects are ramping up or tapering down to support collaborators as they navigate Lilly processes
• Coordinate cross-functional and cross-BU logistics for HCI execution, including working across Medical Affairs, E&C, Legal, and external partners (health systems, professional societies, research institutes)
• Support requests for more information, work orders, change of scope requests, payments, budget tracking and reconciliation, and milestone monitoring for assigned HCIs, including monitoring spend against plan and flagging variances; understand relevant internal/external funding regulations well enough to catch compliance issues early
• Compile, organize, and quality-check data and materials for HCI measurement and reporting, working with the HCI Lead to ensure metrics reflect both system-level change and patient-level outcomes
• Prepare and help synthesize materials for external meetings, internal leadership discussions, HCI Steering Committees and other governance forums; capture decisions and action items and drive follow-through
• Help maintain the HCI technology/ecosystem tools (e.g., trackers, dashboards, collaboration platforms) used to manage the portfolio
• Lead landscape analyses of new disease state, new HCI area of focus or new approach
• Identify opportunities to standardize or streamline recurring operational processes across the HCI portfolio and bring forward improvement ideas rather than waiting to be told what to fix
• Additional operational tasks as warranted by portfolio demands and HCI Lead needs

Your Profile:

• Bachelor's degree.
• 5+ years of program/project management experience, ideally supporting complex, multi-stakeholder initiatives.
• Direct experience or meaningful exposure to healthcare, healthcare systems, or health-related programs (e.g., prior work in/with health systems, payers, provider organizations, public health, medical societies, or pharma/biotech).
• Demonstrated ability to manage budgets, timelines, and multiple workstreams simultaneously with high attention to detail and follow-through.
• Exposure to quality improvement, performance improvement, or implementation-improvement science methodology (even if not the primary role) , e.g., familiarity with IHI models, PDSA cycles, or similar frameworks
• Ability to influence with diplomacy
• High level of experience with Claude and/or Co-pilot
• Experience with public-private partnerships
• Experience in managing relationship and work plans with external partners

Rewards & Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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