In this highly consultative role, you will partner with pharmaceutical and biotechnology clients to translate complex clinical study protocols into effective IRT system designs that ensure patients receive the correct study treatment throughout the trial. You will act as a trusted advisor to clients, providing expert guidance on system strategy, study configuration, and best practices while managing projects through the full lifecycle from design to go-live.

Key Responsibilities

IRT System Design & Client Consultation

• Review and analyse clinical study protocols to understand study objectives and system requirements.
• Partner with clients to design IRT solutions that align with protocol requirements and operational goals.
• Provide strategic guidance and recommendations on optimal system design and study setup.
• Author and maintain detailed user requirements and design documentation.
• Collaborate with clients and internal stakeholders to review, refine, and approve system requirements.

Project Management & Delivery

• Lead the end-to-end delivery of assigned IRT studies, ensuring project milestones and timelines are achieved.
• Manage study implementation activities to support successful study launch ahead of First Patient In (FPI).
• Monitor project scope, identify potential risks, and manage change requests and budget impacts where required.
• Coordinate cross-functional teams to ensure successful execution of project deliverables.
• Conduct system quality reviews and support client demonstrations throughout the project lifecycle.

User Acceptance Testing (UAT)

• Coordinate and support internal and client-facing User Acceptance Testing activities.
• Work closely with technical and validation teams to ensure systems meet study requirements.
• Guide clients through the UAT process and provide expert support in resolving questions and issues.
• Ensure testing outcomes are accurately documented and implemented before production release.

Leadership & Continuous Improvement

• Serve as a subject matter expert (SME) for IRT system design and implementation.
• Contribute to process improvement initiatives, standards development, and lessons learned activities.
• Support protocol amendment activities and system enhancements throughout the study lifecycle.
• Deliver comprehensive study handovers and training to operational teams.
• Mentor junior team members and contribute to technical training programmes.
• Support client meetings, bid defence presentations, quarterly business reviews, and audit activities as required.

Qualifications & Experience

• Bachelor's degree or equivalent combination of education, training, and experience.
• Several years of experience in clinical research, clinical technology, project management, or a related field.
• Hands-on experience delivering and managing Interactive Response Technology (IRT) solutions.
• Strong understanding of clinical trial operations, patient randomisation, and clinical supply management processes.
• Experience working directly with sponsors, CROs, or other external stakeholders.
• Proven ability to interpret clinical protocols and translate requirements into effective system solutions.

Skills & Competencies

• Strong client-facing consulting and relationship management skills.
• Excellent project planning, organisation, and prioritisation abilities.
• Exceptional written and verbal communication skills.
• Strong analytical and problem-solving capabilities.
• Ability to manage multiple projects and deadlines in a fast-paced environment.
• High attention to detail and commitment to delivering quality outcomes.
• Collaborative team player with the ability to work independently.
• Proficiency with Microsoft Office and other business applications.

Why Join Us? As an IRT Systems Project Manager, you will play a critical role in the successful execution of clinical trials that help bring innovative therapies to patients around the world. You will work closely with leading pharmaceutical and biotechnology companies, collaborate with global experts, and contribute to the delivery of technologies that support life-changing research.

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The successful candidate will be responsible for coordinating the development of investigator grants and estimates, contracting strategies, and proposal text to support the proposal development process.

Key responsibilities include:

• Developing contract language, payment language, and budget templates as required
• Utilizing and maintaining contracting systems, tools, processes, and training materials for selected sponsors, studies, or multi-protocol programs
• Ensuring collaboration with sponsors, stakeholders, and RSU regions and countries to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan
• Providing specialist legal, operational, and financial contracting support to Study Teams to facilitate efficient business development and initiation and maintenance of clinical trials
• Ensuring overall contracting efficiency and adherence to project timelines and financial goals
• Reporting contracting performance metrics and out-of-scope contracting activities as required
• Working with Quality Management to ensure appropriate contract management and quality standards
• Mentoring and coaching colleagues as required, including the delivery of training materials

To be considered for this role, you will need:

• A Bachelor's Degree in a related field or 5 years of relevant sponsor or clinical research organization clinical site contracting experience
• Good negotiating and communication skills with the ability to challenge
• Strong legal, financial, and/or technical writing skills
• A strong understanding of the regulated clinical trial environment and knowledge of the drug development process
• Good understanding of clinical trial contract management
• Fluency in English

IQVIA is committed to integrity in our hiring process and maintains a zero-tolerance policy for candidate fraud.

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Your mission: Find your purpose, leverage your strengths, and create projects, tools, and experiences that make a significant impact.

Our culture: We offer freedom and responsibility, allowing you to think big, choose your approach, and turn important things into reality.

Requirements:

• Develop and execute marketing and sales plans
• Build and maintain the Red Bull brand
• Expand consumption among students and beyond

What we offer:

• Opportunity to work with a global brand
• Freedom and responsibility to manage your work
• Chance to develop your skills and strengths

How to apply: Send your application, including your personality and motivation, to join the Red Bull team.

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Essential Functions

• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

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Responsibilities

• Lead complex global Regulatory Affairs programs, ensuring successful delivery across multiple projects, workstreams and functional teams.
• Act as a strategic partner and senior point of contact for clients, providing program leadership and executive-level stakeholder management.
• Establish and maintain program governance structures, oversight plans, KPIs and delivery frameworks.
• Drive program planning, financial management, forecasting, resource strategy and operational execution.
• Oversee cross-functional regulatory teams spanning Regulatory Strategy, Regulatory Operations, Submissions, Labeling, CMC, Safety, Regulatory Intelligence and Lifecycle Management.
• Identify program risks, dependencies and opportunities, developing proactive mitigation and escalation strategies.
• Ensure delivery of high-quality regulatory solutions that meet client objectives, business requirements and regulatory expectations.
• Monitor program performance, profitability, utilisation and revenue realisation, taking corrective action where needed.
• Lead governance meetings, steering committees and executive business reviews with clients and senior internal stakeholders.
• Provide strategic oversight and guidance on regulatory delivery models, resourcing approaches and operational best practices.
• Partner with Business Development, Consulting and Subject Matter Experts to develop client solutions and expand existing relationships.
• Lead proposal development, bid defence activities, scope definition, pricing discussions and resource planning for new opportunities.
• Identify opportunities for account growth and contribute to the expansion of IQVIA's Global Regulatory Affairs offerings.
• Mentor project managers and other team members, promoting knowledge sharing, capability development and delivery excellence.
• Drive continuous improvement initiatives and contribute to the evolution of regulatory program management practices across the organisation.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs or a related discipline. Advanced degree preferred.
• Significant experience within Regulatory Affairs, Regulatory Operations, Regulatory Strategy or related pharmaceutical regulatory functions.
• Proven experience leading large, complex global programs or portfolios within a CRO, pharmaceutical or biotechnology environment.
• Strong understanding of global regulatory frameworks, submission management, product lifecycle management and drug development processes.
• Professional fluency in English and French is required, including the ability to lead client meetings, manage complex stakeholder discussions and contribute to business development activities in both languages.
• Demonstrated success managing complex client engagements and building long-term strategic partnerships.
• Experience leading cross-functional and geographically dispersed teams in matrix environments.
• Strong financial acumen with experience managing program budgets, revenue forecasts, profitability and resource planning.
• Experience overseeing multiple concurrent projects, priorities and stakeholders.
• Proven contribution to business development activities including proposals, bid defences, solution design and client presentations.
• Excellent communication, negotiation and influencing skills, including experience engaging executive-level stakeholders.
• Strong analytical, problem-solving and decision-making capabilities.
• PMP, PRINCE2 or equivalent project/program management certification is advantageous.

Preferred

• Experience leading global or regional Regulatory Affairs programs for large pharmaceutical or biotechnology organisations.
• Experience managing strategic accounts and long-term client partnerships.
• Regulatory consulting experience within a CRO or professional services environment.
• Experience with Veeva Vault RIM, Regulatory Information Management systems and digital regulatory technologies.
• Experience supporting European regulatory procedures, Clinical Trial Applications, lifecycle management and global Health Authority interactions.
• Knowledge of emerging regulatory trends, digital transformation and AI-enabled regulatory solutions.
• Experience participating in organisational growth initiatives, capability development or practice leadership.

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Responsibilities:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications:

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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In this role, you will provide essential support to project teams in the successful execution of clinical trials across a variety of therapeutic areas. You will be responsible for managing study documentation, maintaining trial-related systems and records, coordinating communications with internal stakeholders and research sites, and ensuring that study activities are completed in accordance with applicable procedures and timelines.

Responsibilities

• Perform daily administrative activities to ensure a complete and accurate Trial Master File delivery.
• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Required Knowledge, Skills and Experience

• Bachelor’s or higher-level Degree in life science or an apprenticeship in life science or office management plus administrative experience, preferably in the medical or pharmaceutical field.
• Minimum of 3 years clinical research experience strongly preferred.
• Written and verbal communication skills including good command of English language.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Effective communication, organisational and planning skills.
• Ability to work independently and to effectively prioritise tasks while working on multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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As a Site Activation Specialist, you will:

• Serve as the primary point of contact (SPOC) for investigative sites during feasibility and site activation activities.
• Coordinate site start-up and maintenance activities in compliance with local and international regulations, SOPs, and project requirements.
• Prepare, review, and manage essential site documentation, ensuring accuracy, completeness, and compliance.
• Track and follow up on regulatory, ethics, and contractual submissions and approvals.
• Submission of revised core study documents (rCSD) in CTIS (Romania) and RA & EC in Moldova.
• Site facing responsibilities (communication with PIs and site responsible persons).
• Update of ISF binders with rCSD.
• TMF upload & system tracking.
• If needed, CTA amendments for allocated studies (optional skills for this).
• Communicate document completion and activation milestones to project teams and stakeholders.
• Partner closely with Site Activation Managers, Clinical Operations teams, Project Managers, and other internal stakeholders.

We are looking for candidates with:

• Bachelor's Degree in Life Sciences, Healthcare, Pharmacy, Nursing, Biology, or a related field.
• 1 year of clinical research, site activation, regulatory affairs, clinical operations, or related healthcare experience.
• Alternatively, an equivalent combination of education, training, and relevant experience.
• Approximately 3 years of experience within a healthcare, pharmaceutical, CRO, or clinical research environment (preferred).
• Experience working with site activation, regulatory submissions, clinical trial documentation, or site management activities (preferred).
• Strong organizational skills and attention to detail.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Excellent communication and stakeholder management skills.

Language requirements:

• Romanian: Native.
• English: Advanced (written and spoken).

In return, we offer:

• Hybrid working model.
• Opportunity to work on international clinical research projects.
• Professional development and career growth within a global organization.
• Collaborative and inclusive work environment.
• Competitive compensation and benefits package.

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Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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We are seeking an experienced Regulatory Affairs professional with significant expertise in Advertising & Promotion (Ad/Promo), promotional material review, labelling and artwork activities. This role combines technical regulatory leadership with involvement in customer proposals, bid defense support and cross-functional business development activities.

Responsibilities

• Act as a subject matter expert for advertising and promotion, promotional material review, labelling and artwork-related activities.
• Review promotional and non-promotional materials to ensure alignment with approved product information and applicable regulatory requirements.
• Provide practical regulatory guidance on promotional claims, messaging, product information consistency and compliance expectations.
• Partner with medical, legal, commercial, quality, labelling and operational colleagues to identify and mitigate regulatory risks.
• Coordinate and deliver Ad/Promo regulatory review activities while ensuring high-quality, timely execution.
• Track deliverables, open issues, risks and project dependencies to support effective project oversight.
• Support proposal development, budget preparation, bid defense activities and customer responses as a Product Specialist.
• Coordinate input from regulatory experts and cross-functional stakeholders to develop compelling customer solutions.
• Contribute to customer-facing proposal content and support bid defense preparation and presentation activities.
• Translate complex regulatory requirements into practical, commercially relevant recommendations that support customer objectives.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or another relevant scientific discipline.
• Extensive Regulatory Affairs experience within the pharmaceutical, biotechnology or healthcare industry.
• Strong hands-on experience in advertising and promotion (Ad/Promo), promotional material review, promotional compliance, labelling, artwork and related regulatory review activities.
• Strong understanding of promotional and non-promotional material review principles and regulatory compliance requirements.
• Experience partnering with medical, legal, commercial and operational stakeholders in a matrix environment.
• Excellent organisational skills with the ability to manage multiple priorities and coordinate diverse stakeholder groups.
• Strong communication and stakeholder management skills.
• Ability to work independently while maintaining a strong customer focus and delivery mindset.

Nice to Have

• Experience supporting proposals, budgets, bid defense meetings or other pre-award activities.
• Broader lifecycle management or post-marketing regulatory experience.
• Experience gained within a CRO, consultancy or client-facing regulatory environment.
• Experience coordinating complex initiatives across multiple functions, countries or business units.
• Exposure to customer-facing interactions and presentation activities.

Benefits

• Develop and apply deep Ad/Promo regulatory expertise.
• Work with global pharmaceutical and biotech clients.
• Gain exposure to strategic proposal and business development activities.
• Collaborate with cross-functional experts across IQVIA.
• Contribute to innovative regulatory solutions in a fast-paced, international environment.
• Build a career pathway towards senior subject matter expert, Product Specialist leadership, Associate Director or broader Global Regulatory Affairs leadership opportunities.

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We are seeking an experienced Regulatory Affairs professional with deep expertise in European regulatory affairs and biologic products. This role is ideal for a senior regulatory specialist who enjoys managing complex market applications, lifecycle management activities and post-marketing submissions while acting as a trusted advisor to customers and internal stakeholders.

Responsibilities

• Provide regulatory expertise for European market applications and post-marketing activities across the product lifecycle.
• Support the development and execution of regulatory strategies for biologic products.
• Prepare, coordinate and review regulatory submissions, including market applications, lifecycle management activities, labelling updates and CMC-related variations.
• Support regulatory activities across Centralised, Decentralised, Mutual Recognition and national procedures.
• Identify regulatory risks and provide practical recommendations to support successful project delivery.
• Serve as a subject matter expert for post-marketing regulatory activities, including variations, renewals, maintenance activities and labelling changes.
• Collaborate closely with CMC, clinical, safety, quality, labelling and project management stakeholders.
• Participate in customer interactions, project meetings and governance discussions, providing clear regulatory guidance and recommendations.
• Support continuous improvement initiatives and contribute to high-quality regulatory delivery across global programmes.
• Ensure regulatory deliverables meet required quality, compliance and timeline expectations.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or another relevant scientific discipline.
• At least 8 years of Regulatory Affairs experience.
• Strong expertise in European regulatory requirements, procedures and submission pathways.
• Proven experience supporting or managing market applications and post-marketing regulatory activities across the product lifecycle.
• Strong knowledge of lifecycle management, variations, renewals and maintenance activities.
• Experience managing labelling updates and CMC-related regulatory activities.
• Experience working with biologic products is essential.
• Ability to work independently as a regulatory subject matter expert within a matrixed and client-focused environment.
• Excellent communication and stakeholder management skills.

Additional Experience That Will Help You Stand Out

• Experience supporting complex European regulatory procedures.
• Broad exposure to CMC regulatory activities.
• Experience working within a CRO, consultancy or outsourced services environment.
• Experience partnering with global cross-functional teams.
• Customer-facing regulatory experience.
• Experience supporting multiple products, markets or regulatory programmes simultaneously.

Why IQVIA?

Joining IQVIA means becoming part of a global team of regulatory experts supporting the development and lifecycle management of medicines that improve patient outcomes around the world.

In this role, you'll have the opportunity to:

• Build deep expertise in biologics and European regulatory affairs.
• Work on complex regulatory programmes across multiple markets.
• Partner with leading pharmaceutical and biotechnology companies.
• Collaborate with global experts across regulatory, quality, safety, clinical and CMC functions.
• Contribute to innovative regulatory solutions in a highly collaborative environment.
• Progress toward Associate Director, senior SME and broader Global Regulatory Affairs leadership opportunities.

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Responsibilities

• Assist Clinical Research Specialists, Clinical Research Associates, and Regulatory and Start-Up teams with accurately updating and maintaining clinical systems to track site compliance and performance within project timelines.
• Prepare, handle, distribute, file, and archive clinical documentation and reports according to the scope of work and standard operating procedures, and periodically review study files for completeness.
• Assist with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Track and manage Case Report Forms, queries, and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
• May accompany Clinical Research Associates on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
• Perform assigned administrative tasks to support team members with clinical trial execution.

Required Knowledge, Skills, and Abilities

• Awareness of applicable clinical research regulatory requirements, such as Good Clinical Practice and International Conference on Harmonization guidelines.
• Knowledge of applicable protocol requirements as provided in company training.
• Computer skills, including working knowledge of Microsoft Word, Excel, and PowerPoint.
• Good written and verbal communication skills, including good command of English language.
• Effective time management and organisational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Minimum Required Education and Experience

• High or Secondary School diploma/certificate or country's educational equivalent and 3 years administrative support experience; or equivalent combination of education, training, and experience.

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This internship offers an excellent opportunity to develop analytical skills, work with industry-leading reporting tools, and collaborate with experienced professionals across Clinical Operations.

Key Responsibilities

• Support Reporting & Data Management Activities
• Assist in the preparation, maintenance, and validation of operational reports and dashboards that support Clinical Operations and portfolio management activities.

• Analyze Data & Identify Trends
• Review clinical and operational data to identify trends, inconsistencies, and opportunities for improvement.
• Investigate root causes and contribute to data-driven decision-making processes.

• Prepare Management Review Materials
• Support the creation of presentations, summaries, and reporting packages for management reviews.
• Ensure information is accurate, clear, and delivered on time.

• Collaborate Across Multiple Teams
• Coordinate data collection and follow-up activities with stakeholders across Clinical Operations.
• Help consolidate and organize information from various functions and teams.

• Develop Expertise in Clinical Reporting Tools
• Learn and work with internal reporting systems and analytical tools, including Excel, Power BI, Smartsheet, Spotfire, and related platforms.
• Gradually take on increased analytical responsibilities as your skills develop.

Ideal Candidate

We're looking for someone who is curious, analytical, and eager to learn.

You may be a great fit if you have:

• A strong interest in analytics, reporting, and problem-solving.
• Basic to intermediate Excel skills.
• Familiarity with Power BI, Smartsheet, Spotfire, or Python (considered an advantage).
• A proactive mindset and the ability to work independently.
• Strong critical-thinking skills and the confidence to ask insightful questions.
• An educational background in Health Sciences, Medicine, Economics, Business, Mathematics, Statistics, or a related field (beneficial but not required).

No previous professional experience is required.

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