Job Responsibilities

• Safeguard the wellbeing of research subjects in a medical capacity, ensuring that all procedures are conducted with the highest standards of care and safety
• Review study protocols and execute procedures in alignment with protocols and regulatory, health, and safety standards
• Recruit and coordinate communication with clinical trial volunteers and patients, maintaining clear and effective communication throughout the study
• Follow applicable regulations globally and by region, ensuring that all activities are conducted in accordance with local and international standards
• Collaborate with cross-functional teams to develop study materials, including informed consent forms, study manuals, and other essential documents
• Monitor trial progress and address any issues that arise during the study
• Provide organizational related support or service, typically under supervision, assisting with administrative tasks and other support activities as needed
• Perform routine tasks with some deviation from standard practice, adapting to changing circumstances and requirements as necessary
• Utilize broad knowledge of operational systems and practices gained through extensive experience and/or education, applying this knowledge to improve study processes and outcomes

Qualifications

• High school diploma or equivalent required
• Associate's degree or higher in a related field preferred
• Minimum of 2 years of experience in clinical operations or a related field
• Strong understanding of clinical research protocols and regulatory requirements

Certifications

• Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred
• Basic Life Support (BLS) certification required

Necessary Skills

• Excellent communication and interpersonal skills
• Strong organizational and time management abilities
• Attention to detail and accuracy in documentation
• Ability to work effectively in a team environment
• Proficiency in Microsoft Office Suite and clinical trial management software

XML job scraping automation by YubHub

As a Project Manager II, you will plan, direct, create, and communicate clinical study timelines to ensure deliverables are produced on schedule. You will gather input from cross-functional teams to create comprehensive plans for clinical studies and ensure consistency of clinical study processes across clinical trials.

Key responsibilities:

• Plan and manage clinical study timelines
• Collaborate with cross-functional teams to integrate their feedback into study plans
• Ensure consistency of clinical study processes across trials
• Oversee and resolve operational aspects of clinical trials
• Select sites and vendors, prepare clinical trial budgets
• Monitor progress and follow up with team members and line managers
• Implement and prepare clinical development strategies
• Develop trial recruitment strategies

Requirements:

• Bachelor's degree in a related field (e.g., Clinical Research, Life Sciences, Healthcare Management)
• Minimum of 5 years of experience in clinical project management or a related role
• Proven track record of successfully managing clinical trials
• Certification in Clinical Research (e.g., CCRP, CCRA) is preferred
• Project Management Professional (PMP) certification is a plus

Necessary skills:

• Strong organizational and planning skills
• Excellent communication skills
• Ability to oversee and resolve operational aspects of clinical trials
• Knowledge of SOP, GCP, and country regulations
• Experience in site and vendor selection, budget preparation, and monitoring progress
• Strong problem-solving skills

XML job scraping automation by YubHub

Responsibilities:

• Lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Produce site-specific contracts from country clinical trial agreement (CTA) template.
• Negotiate budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Perform quality control and arrange execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Administer all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• Generate amended contract and/or budget documents as necessary.
• Work closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
• Identify possible contract or process operational risk and proactively work within the team to provide solutions.
• Provide support to business development and represent site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Collaborate with internal and external legal, finance, and clinical operations departments.
• Maintain and actively support review and development of contract templates, budget templates and site specific files and databases.
• Serve as key communication liaison between site contracts staff and internal and external customers.
• Train and mentor less experienced staff members on departmental Standard Operating Procedures (SOPs).

Qualifications:

• BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
• Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry.
• Strong knowledge of the clinical development process and legal and contracting parameters.
• Strong computer skills in Microsoft Office Suite.
• Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations.
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
• Good understanding clinical protocols and associated study specifications.
• Excellent understanding of clinical trial start-up processes.
• Project management experience in a fast-paced environment.
• Good vendor management skills.
• Strong organizational skills with proven ability to handle multiple projects.
• Excellent communication, presentation and interpersonal skills.
• Quality-driven in all managed activities.
• Strong negotiating skills.
• Strong problem-solving skills.
• Ability to mentor and motivate more junior staff.

Benefits: Syneos Health offers a comprehensive benefits package, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

Salary: The annual base salary for this position ranges from $56,000 to $95,000.

XML job scraping automation by YubHub

Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage and direct the work of lower-level professionals or manage processes and programs
• Ensure accurate and timely documentation and reporting of clinical trial data
• Collaborate with cross-functional teams to support clinical trial activities
• Identify and resolve issues related to clinical trial conduct and data integrity
• Provide training and mentorship to junior staff members

Qualifications

• Bachelor's degree in a related field
• Minimum of 3-5 years of experience in clinical research or a related field
• In-depth knowledge of clinical trial processes and regulations
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Certifications

• Certified Clinical Research Professional (CCRP) or equivalent certification preferred

Necessary Skills

• Proficiency in clinical trial management systems and software
• Strong organizational and time management skills
• Attention to detail and accuracy
• Ability to manage multiple projects and priorities simultaneously
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

XML job scraping automation by YubHub

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage and direct the work of lower-level professionals or manage processes and programs
• Ensure accurate and timely documentation and reporting of clinical trial data
• Collaborate with cross-functional teams to support clinical trial activities
• Identify and resolve issues related to clinical trial conduct and data integrity
• Provide training and mentorship to junior staff members

Qualifications:

• Bachelor's degree in a related field
• Minimum of 3-5 years of experience in clinical research or a related field
• In-depth knowledge of clinical trial processes and regulations
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Certifications:

• Certified Clinical Research Professional (CCRP) or equivalent certification preferred

Necessary Skills:

• Proficiency in clinical trial management systems and software
• Strong organizational and time management skills
• Attention to detail and accuracy
• Ability to manage multiple projects and priorities simultaneously
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

XML job scraping automation by YubHub

Job Responsibilities

• Compiles, writes, and edits medical writing deliverables, serving as a medical writer within and across departments with moderate supervision.
• Develops or supports various documents, including:
• Clinical study protocols and amendments
• Clinical study reports
• Patient narratives
• Investigator brochures
• Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
• Interacts with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
• Adheres to established regulatory standards, including ICH-E3 guidelines and Company Standard Operating Procedures.
• Performs online clinical literature searches as applicable.
• Continues professional development to keep pace with regulatory guidance and client expectations.
• Is aware of budget specifications for assigned projects, working within budgeted hours and communicating changes to medical writing leadership.
• Completes required administrative tasks within specified timeframes.
• Performs other work-related duties as assigned, with minimal travel (less than 25%).

Requirements

• Minimum 1 year of experience in clinical trial disclosure or CTT.
• Good experience in protocol registration and result registration.
• Experience with results posting for regulatory bodies.

What We Offer

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Total Self culture, allowing you to authentically be yourself

XML job scraping automation by YubHub

Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
• Evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions
• Verify process of obtaining informed consent has been adequately performed and documented for each subject/patient
• Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
• Conduct Source Document Review of appropriate site source documents and medical records
• Verify required clinical data entered in the case report form (CRF) is accurate and complete
• Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary
• Utilize available hardware and software to support the effective conduct of the clinical study data review and capture
• Verify site compliance with electronic data capture requirements
• Perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution
• Understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met
• Act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate
• Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings
• Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

XML job scraping automation by YubHub

The Sample Management Specialist II is responsible for managing samples, including receipt, inventory, chain of custody, storage, transfers, and disposition. The ideal candidate will have experience with end-to-end sample management processes and be skilled in operating and troubleshooting storage appliances and environmental monitoring systems.

Core Responsibilities

• Receive, control, and dispose of study samples and reference materials
• Manage shipping and receiving samples, including destruction and transfer as directed by clients
• Provide samples and materials to laboratory staff for analysis
• Maintain inventory of supplies and order new supplies as needed
• Assist with maintenance, operation, and support of sample storage equipment and monitoring systems
• Archive documents related to sample management

Qualifications

• High school diploma
• Excellent communication, presentation, and interpersonal skills
• Good computer skills, including Microsoft Word and Excel
• Ability to use sample-tracking software
• Bilingualism in English and Spanish, with understanding of simple messages and basic instructions

What We Offer

Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and total rewards programs.

XML job scraping automation by YubHub

Responsibilities:

• Audit selected expense reports and related receipts in accordance with Travel and Expense Policy and Business Conduct Standards and approve for payment.
• Collect, analyze, and interpret information to assess and conclude on each assigned audit area.
• Prepare clear and concise documentation to adequately support all audit area conclusions and findings.
• Monitor and complete problematic expense reports that are in a pending status waiting for additional research and resolution.
• Review previous audit annotations, reports, approvals, and additional on-file information.
• Regularly monitor and respond to Expense Reporting voicemail and email.
• Respond to a high volume of employee inquiries in a prompt, accurate, and professional manner.
• Correctly answer employee questions regarding system issues, Travel Policy, and Business Conduct Standard reimbursement guidelines.
• Assist in identifying improvement opportunities and shares best practices within department.
• Assist in identifying potential partnerships between Expense Reporting and the various functional areas and business units throughout the Company.
• Cross train to perform back up functions for higher-level accounting clerks as directed or assigned.
• Produce required daily, weekly, and monthly reports relating to expense report auditing.

Qualifications:

• Bachelor’s degree required (Preferably in Commerce)
• Required 1-2 years of Travel & Expense process and Expense audit experience.
• Preferred to have experience on any expense tool like Concur / I-Expense/Workday etc.
• Expense audit experience is a preference
• Customer service experience
• Strong oral and written communication skills
• Proficient at Microsoft Excel and PowerPoint
• Ability to perform day-to-day functions with limited supervision; ability to interact comfortably with individuals from various business units.
• Good analytical skills and a strong attention to detail.
• Impeccable organization skills, strong interpersonal skills and the flexibility to handle multiple tasks simultaneously.
• Strong Customer Relation Skills.
• Strong Math Aptitude.
• Time Management Skills.
• Able to work independently and as part of a team.
• Problem solving ability.
• Flexible and able to adapt to shifting priorities and responsibilities in a dynamic and changing environment.

XML job scraping automation by YubHub

Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

XML job scraping automation by YubHub

In this role, you will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO,offering the best of both worlds: sponsor collaboration and CRO resources.

Responsibilities:

• In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
• Communicates with functional peers regarding project status and issues and ensure project team goals are met
• Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out
• Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report)
• Coordinates data review to support interim/final data analysis
• Participates in study strategy development
• Maintains study timelines
• Contributes to development of study budget
• Contributes to development of RFPs and participate in selection of CROs/vendors
• Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management)
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
• Participates in the recruiting and hiring process for CPA/CTMAs and supports their professional development
• Coaches members of a work team and ensures adherence to established guidelines

Requirements:

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
• Extensive Study Start-up Experience
• Global clinical trial experience
• Prior involvement in Inflammation studies
• Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
• Highly developed leadership skills to successfully lead a clinical study team
• Ability to deal with time demands, incomplete information or unexpected events
• Must display strong analytical and problem solving skills
• Attention to detail
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities

Benefits:

• Company car or car allowance
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time

XML job scraping automation by YubHub

Responsibilities:

• Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate oversight from the SSU Country Manager.
• Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Requirements:

• Bachelor’s Degree.
• Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
• Ability to understand clinical protocols and associated study specifications.
• Detailed understanding of clinical trial start-up processes.
• Ability to manage external vendors to contract effectively.
• Strong organizational skills with ability to handle multiple tasks effectively.
• Strong written and verbal communication and interpersonal skills.
• Ability to manage multiple project budgets with increased complexity and value.
• Quality-driven in all managed activities.
• Good negotiating skills.
• Good problem-solving skills.
• Demonstrated ability to work independently as well as part of a team.

XML job scraping automation by YubHub

Responsibilities:

• Review protocol, critical data, and process, safety, and data integrity risks related to protocol execution
• Review patient data listings and visualizations via analytical dashboards and/or reports
• Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
• Immediately communicate/escalate serious issues to the project team and develop action plans
• Document observations noted during reviews and write queries, protocol deviations, or action items as necessary
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Access vendor systems or reports to verify IP dispensing and administration, laboratory procedures, and eTMF data
• Document completion of activities via tracking, reporting, and/or other required project documents
• Understand project scope, budgets, and timelines; manage patient- and site-level activities to ensure project objectives, deliverables, and timelines are met
• Adapt to changing priorities to achieve goals/targets
• Prepare for and attend Investigator Meetings and/or sponsor meetings

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Mastery of MS Excel (sorting, filtering, calculating, pivoting)
• Proficient with Analytical Data Visualization Tools
• Excellent verbal and written communication skills
• Strong analytical skills
• Developing therapeutic expertise
• <10% travel (limited to trainings, investigator meetings)

XML job scraping automation by YubHub

The successful candidate will be responsible for providing quality on deliverables at the country level, following project requirements and applicable country rules, with oversight from the SSU Country Manager.

Key responsibilities include:

• Monitoring and reporting on project milestones and timelines
• Ensuring compliance with Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Preparing and submitting regulatory applications and approvals
• Acting as a liaison between investigational sites and functional leads
• Providing support with site selection, feasibility, and contract negotiation

The ideal candidate will have:

• An associate degree or equivalent combination of education and training
• Good understanding of clinical trial processes across Phases II-IV and ICH GCP
• Excellent organizational and communication skills
• Ability to work independently and as part of a team
• Strong computer skills, including Word, Excel, PowerPoint, and Publisher

Syneos Health offers a dynamic and supportive work environment, with opportunities for career development and growth.

XML job scraping automation by YubHub

Job Responsibilities

As an Associate Director, you will manage Product Managers and UX Designers, onshore and offshore, and own a discipline within the department. You will lead the creation of the overall product vision and roadmap in partnership with leadership, and establish a cohesive product strategy and roadmap across proposal, pricing, and contracting technologies.

Key responsibilities include:

• Managing a global team and directly owning one or more complex products
• Translating and prioritizing business needs into technical and analytical requirements
• Overseeing prioritization of product features and communicating priorities to development teams
• Partnering with data scientists and engineers on requirements and statements of work
• Identifying unresolved business needs and using them to guide product strategy
• Driving product strategy, discovery, business-case development, delivery, adoption, and value realization
• Leading process standardization and technology adoption across businesses, functions, and geographies
• Managing vendors, implementation partners, budgets, contracts, and product evaluations
• Building strong relationships across Sales, Proposal Management, Pricing, Legal, Finance, Operations, Data, Technology, and external partners

Experience Requirements

To be successful in this role, you will need:

• 6+ years of product management experience in deal-management technology within an enterprise sales setting
• Experience managing enterprise products through strategy, discovery, business-case development, delivery, adoption, and value realization
• People-management experience, including coaching Product Managers and setting objectives
• Experience owning a portfolio of interconnected products while directly managing one or more complex products
• Strong understanding of the end-to-end deal lifecycle and experience integrating proposal, pricing, and contracting products with CRM, finance, legal, data, and delivery systems

Relevant Enterprise Platforms

Familiarity with the following platforms is required:

• Proposal and RFP management tools such as Qvidian or QorusDocs
• Pricing, CPQ, or deal-desk solutions
• Contract lifecycle management and electronic-signature platforms
• Salesforce or another enterprise CRM
• Document generation, content repositories, workflow, analytics, and AI capabilities

Skills & Capabilities

The ideal candidate will have:

• Ability to balance portfolio leadership, people management, and direct ownership of critical products
• Strong product discovery, prioritization, backlog management, and value-measurement capabilities
• Strong people leadership, including coaching, delegation, performance management, and development of product-management capabilities
• Technical fluency in enterprise architecture, integrations, APIs, data models, document automation, workflow automation, analytics, and generative AI

XML job scraping automation by YubHub

Responsibilities:

• Ensure quality deliverables at the country level, following project requirements and applicable country rules
• Monitor basic financial aspects of the project and escalate discrepancies in a timely fashion
• Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner
• Support continuous improvement of quality in all Site Start-Up (SSU) components at the country level
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
• Act as a point of contact for the PM/SAM (or designee) during start-up on allocated projects
• Prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required
• May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues
• Oversee site activation end to end process at country/site level
• Provide support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies
• May be asked to perform Local Investigator Contract and Budget Negotiator tasks

Qualifications:

• Bachelor's Degree
• Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
• Ability to understand clinical protocols and associated study specifications
• Detailed understanding of clinical trial start-up processes
• Ability to manage external vendors to contract effectively
• Strong organizational skills with ability to handle multiple tasks effectively
• Strong written and verbal communication and interpersonal skills
• Ability to manage multiple project budgets with increased complexity and value
• Quality-driven in all managed activities
• Good negotiating skills
• Good problem-solving skills
• Demonstrated ability to work independently as well as part of a team

XML job scraping automation by YubHub

• Managing quality deliverables and tracking milestone progress
• Monitoring financial aspects of projects and escalating discrepancies
• Reviewing and complying with Standard Operating Procedures (SOPs) and Work Instructions (WI)
• Supporting continuous improvement of quality in Site Start-Up (SSU) components
• Acting as a liaison and facilitator between investigational sites and functional leads
• Providing local regulatory intelligence and supporting data protection activities
• May be asked to perform additional tasks such as Local Investigator Contract and Budget Negotiator

The ideal candidate will have:

• A Bachelor's Degree
• Detailed understanding of clinical trial processes across Phases II-IV and ICH GCP
• Ability to understand clinical protocols and associated study specifications
• Strong organizational and communication skills
• Ability to work independently and as part of a team

Syneos Health offers a range of benefits, including career development and progression opportunities, supportive line management, technical and therapeutic area training, and a total rewards program.

XML job scraping automation by YubHub

Job Responsibilities

• Manage all Site Identification activities to ensure quality, on-time deliverables that are within budget.
• Understand and translate protocol requirements to develop the ideal site profile, in collaboration with Sponsor and key cross-functional leads.
• Develop the Site Identification plan (Site ID checklist), with input from the Sponsor and Project Lead (PL).
• Lead the technical and operational site identification aspects of global projects, including tracking and weekly reporting of project deliverables.
• Manage site identification related resource management for studies.
• Project-specific financial management, including understanding costing tool, revenue recognition, and forecasting units.
• Train and mentor site identification project team members on project protocol, study-specific requirements, and the site identification process.
• Analyze survey data and produce final site identification deliverable, including site identification recommendations.

Qualification Requirements

• BA/BS in the biological sciences or related discipline in the natural sciences/health care field (e.g. RN).
• Experience working in a pharmaceutical, biotech, contract research organization, or clinical research site.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, database applications), email, and internet.
• Strong presentation skills, interpersonal skills, as well as a team-oriented approach.
• Excellent verbal, written, communication, and time management skills.
• Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high-quality work.

XML job scraping automation by YubHub

Key Responsibilities

• Analyze HR metrics such as headcount, attrition, and hiring
• Create executive-ready PPT decks for leadership and business reviews
• Convert data into clear visuals, insights, and storyline-driven slides
• Apply data storytelling to structure narratives, highlight key trends, risks, and business impact, and simplify complex data into clear, actionable messages
• Build and maintain standard templates and reporting decks
• Partner with HR, Talent Acquisition, and Finance to deliver actionable insights
• Ensure data accuracy and consistency, and support ad hoc analysis and reporting needs

Required Skills

• 3+ years of experience in HR/Workforce Analytics or Reporting
• Strong understanding of HR metrics
• Advanced PowerPoint skills
• Strong data storytelling and visualization skills, particularly in PPT
• Proficiency in Excel
• Strong analytical and communication skills

Preferred Skills

• Experience with Workday/HR systems
• Experience supporting leadership decks/executive presentations
• Knowledge of presentation design and storytelling best practices

XML job scraping automation by YubHub

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms
• Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates
• Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials
• Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues
• Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans
• Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 3-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

XML job scraping automation by YubHub

Key Responsibilities:

• Develop mock shells, define analysis datasets, and support randomization activities.
• Perform protocol reviews and contribute statistical inputs during study design and execution.
• Review Clinical Study Reports (CSRs) and ensure accuracy and consistency of statistical outputs.
• Support Phase I studies including PK/PD analyses, biomarker evaluations, and clinical pharmacology assessments.
• Validate Tables, Listings, and Figures (TFLs) and ensure compliance with quality standards.
• Work with CDISC standards (SDTM/ADaM) and collaborate with statistical programming teams.
• Apply SAS for statistical analyses and data review activities.

We offer a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

XML job scraping automation by YubHub

The Regulatory Labeling Manager – Lifecycle Products is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products (products that have no additional development activities ongoing).

Key Responsibilities:

• Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews.
• Author and revise labeling documents including the Company Core Data Sheets (CCDSs), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and Rest of World (ROW) labels for lifecycle products.
• Support labeling governance activities by collaborating with the team lead and GLL/RLL to prepare materials, attend the governance meeting, and record accurate minutes.
• Ensure labeling content complies with applicable regulatory requirements (e.g., FDA, EMA, ICH) and internal standards.
• Collaborate with cross-functional teams (e.g., Safety, Medical, Legal, Regulatory Strategy) to gather input and align on labeling changes.

Required Knowledge/Skills:

• Strong understanding of global labeling regulations and guidance (FDA, EMA, ICH).
• Proven experience authoring and maintaining labeling content for approved products.
• Strong command of English language including grammar, spelling, and punctuation.
• Exceptional proofreading and editing skills.
• Strong organizational skills and attention to detail.
• Proficiency in Microsoft Word and document management systems (e.g., Veeva Vault).
• Experience using Label tracking systems, e.g., Intagras, Veeva Labeling.

Typically 2+ years of experience in the biotechnology industry, preferably in Regulatory Affairs, Regulatory Labeling or a related discipline. Minimum Bachelor's degree, in a Science or Business-related field.

XML job scraping automation by YubHub

Job Responsibilities

• Lead end-to-end planning for conferences, meetings and events, including stakeholder coordination, planning materials, calls, sponsorships, hotel blocks, collateral and promotional items.
• Manage external vendors, including exhibit, promotional and printing partners, to deliver business needs within budget.
• Coordinate event promotion with Content Strategy, Digital Analytics and External Communications, including emails, landing pages and social media.
• Support customer-facing teams with attendee lists, CRM campaigns and meeting scheduler training.
• Negotiate contracts with hotels, convention centers, conference associations, speakers and other service providers.
• Develop programs, agendas, budgets and services that meet host requirements and budget targets.
• Build Cvent registration sites and manage registration, attendee communications and related updates.
• Maintain event records and financial details, including final bill review, spend approval and vendor payments.
• Project manage GCC&M Centers of Excellence to support conference and event strategy, goals and objectives.
• Coordinate audio-visual, transportation, displays and other event requirements.
• Evaluate and select service providers based on event requirements.
• Develop and distribute event reports to participants, vendors and other stakeholders as needed.
• Provide post-event analysis, budget recaps and participant feedback to improve future events.
• Plan internal team meetings and events, both in person and virtual, as needed.
• Manage financial tasks, including POs, invoices, budget tracking, monthly accruals and reconciliation.
• Travel up to 25% to support annual sales meetings, conferences and events onsite.

Qualification Requirements

• Bachelor’s degree in hospitality, business, communications or related field.
• 3-5 years of conference, meeting or event planning experience.
• Healthcare, CRO or biopharmaceutical services experience preferred.
• Strong organizational and time management skills.
• Proficiency in Microsoft Excel, PowerPoint and Word, including pivot tables.
• Experience with Cvent or similar event management tools.
• Experience with Trello or similar project management tools.
• Detail-oriented, with the ability to manage multiple projects and competing deadlines.
• Strong problem-solving and troubleshooting skills in a team environment.
• Strong interpersonal, verbal and written communication skills across calls, virtual meetings and in-person settings.
• Ability to present effectively to attendees and senior executives in person or virtually.
• Flexible and adaptable in a fast-paced, dynamic environment.
• Able to work both independently and collaboratively.

XML job scraping automation by YubHub

Responsibilities:

• Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or nonclinical) data using tested or validated software
• Write the pharmacokinetic and statistical sections of clinical (early and late phases) or nonclinical (toxicokinetic studies) reports including interpretation of the results
• Participate in intra and/or extra company scientific consultancy
• Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during clinical studies
• Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid
• Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in inhouse database
• Write/review standard operating procedures related to his/her work
• Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians
• Participate in the development of structured and standardized data modeling practices and related SOPs
• Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.)
• Perform comprehensive quality control/peer review procedures

About Syneos Health: Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. They partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

XML job scraping automation by YubHub

Responsibilities:

• Develops custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets
• Performs validation programming and works with other programmers, biostatisticians, and project team members to resolve discrepancies or findings
• Maintains well-organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities, and adapts to timeline or priority changes
• Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements
• Conducts effective internal meetings and distributes relevant information in advance
• Displays willingness to work with others and assist with projects and initiatives as necessary
• Acts as the lead statistical programmer and directs the programming activities of other programming personnel
• Reviews project documentation and provides feedback to project team members
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative
• Contributes to the mentoring of programming personnel and develops training courses
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements
• Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures
• Contributes technical expertise to the development of programming tools and macros for standardization and efficiency
• Performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets

Qualifications:

• 8+ years of experience in Clinical SAS Programming
• Strong expertise in Base SAS/SAS Macros, SDTM, ADAM & TLF programming, specs creation
• Hands-on experience with both Safety & Efficacy data
• Experience in Oncology therapeutic areas is preferred
• ISS/ISE experience and R programming skills are required
• Excellent written and verbal communication skills
• Ability to read, write, speak, and understand English

XML job scraping automation by YubHub

Key responsibilities include:

• Directing the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work
• Providing independent review of project work produced by other biostatisticians in the department
• Preparing or overseeing the preparation of Statistical Analysis Plans (SAPs)
• Collaborating with sponsors, if required
• Creating or reviewing programming specifications for analysis datasets, tables, listings, and figures
• Reviewing SAS/R annotated case report forms (CRFs), database design, and other study documentation
• Implementing company objectives and creating alternative solutions to address business and operational challenges
• Interfacing with other departmental project team representatives
• Conducting and participating in verification and quality control of project deliverables
• Managing scheduling and time constraints across multiple projects
• Monitoring progress on study activities against agreed-upon milestones
• Providing statistical programming support as needed
• Participating in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities
• Maintaining well-organized, complete, and up-to-date project documentation
• Displaying willingness to work with others and assisting with projects and initiatives as necessary

Requirements:

• Graduate degree in biostatistics or related discipline
• Extensive experience in clinical trials or an equivalent combination of education and experience
• Proficiency in R programming
• Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research
• Experience across all statistical tasks required to support clinical trials during the lifecycle of the project
• Excellent written and verbal communication skills
• Ability to read, write, speak, and understand English

XML job scraping automation by YubHub

The Site Care Partner will perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance. They will use judgment and experience to evaluate the overall performance of the site and site staff and provide recommendations regarding site-specific actions.

Key responsibilities include:

• Performing site qualification, site initiation, interim monitoring, site management, and close-out visits
• Evaluating overall performance of site and site staff and providing recommendations
• Verifying the process of obtaining informed consent has been adequately performed and documented
• Assessing factors that might affect subject/patient's safety and clinical data integrity
• Conducting Source Document Review of site source documents and medical records
• Applying query resolution techniques remotely and on-site
• Utilizing available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifying site compliance with electronic data capture requirements
• Managing site-level activities and communication to ensure project objectives, deliverables, and timelines are met
• Providing guidance at the site and project level towards audit readiness standards
• May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate
• Preparing for and attending Investigator Meetings and/or sponsor face-to-face meetings
• Participating in and may lead global clinical monitoring/project staff meetings
• May provide direct supervision, training, and/or mentorship to more junior level CRAs

The ideal candidate will have:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

XML job scraping automation by YubHub

Job Responsibilities

• Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures (SOPs), and work instructions (WIs), contracts, and project-specific requirements.
• Host and support customer audits and regulatory inspections in accordance with QA SOPs and WIs.
• Plan and conduct assigned audits.
• Write and issue audit reports, ensuring clear communication of audit findings to the auditees and relevant management.
• Review responses to audit findings for appropriateness and completeness.
• Close assigned audits.
• Prepare for and host or support customer audits.
• Assist senior QA personnel in hosting or supporting Regulatory Authority Inspections.

Qualification Requirements

• Bachelor's degree in a science/healthcare field or equivalent with moderate experience in GCP quality assurance auditing.
• Good knowledge of GCP regulatory requirements.
• Knowledge of medical and technical terminology related to the audit types to be conducted.
• Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency).
• Ability to handle multiple tasks to meet timelines in a dynamic environment.
• Strong organizational, presentation, and interpersonal skills.
• Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.
• Ability to negotiate and provide constructive feedback.
• Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.

Benefits

Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

XML job scraping automation by YubHub

Job Summary As an Auditor II, QA, you will conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures (SOPs) and work instructions (WIs), contracts and project-specific requirements. You will also host and support customer audits and regulatory inspections in accordance with QA SOPs and WIs.

Responsibilities

• Plan and conduct assigned audits
• Write and issue audit reports, ensuring clear communication of audit findings to the auditees and relevant management
• Review responses to audit findings for appropriateness and completeness
• Close assigned audits
• Prepare for and host or support customer audits
• Assist senior QA personnel in hosting or supporting Regulatory Authority Inspections
• Perform other work-related duties as assigned

Requirements

• Bachelor's degree in a science/health care field or equivalent with moderate experience in GCP quality assurance auditing
• Good knowledge of GCP regulatory requirements
• Knowledge of medical and technical terminology related to the audit types to be conducted
• Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency)
• Ability to handle multiple tasks to meet timelines in a dynamic environment
• Strong organizational, presentation and interpersonal skills
• Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds
• Ability to negotiate and provide constructive feedback
• Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation

Benefits Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition and total rewards program.

XML job scraping automation by YubHub

The successful candidate will define product vision, strategy, and roadmap based on business, customer, and user needs. They will translate and prioritize business needs into product requirements, user stories, technical requirements, and measurable outcomes.

Key responsibilities include:

• Developing solutions supporting B2B marketing and demand generation, including ABM, lead capture, nurturing, scoring, routing, campaign management, and attribution
• Driving integrations across marketing platforms, Salesforce CRM, websites, customer data platforms, analytics tools, and third-party data providers
• Defining and tracking KPIs, including adoption, funnel performance, lead-to-opportunity conversion, attribution, pipeline contribution, and business value
• Partnering across Marketing, Sales, Technology, Data, Privacy, Security, and Compliance to deliver scalable solutions
• Evaluating and introducing AI-enabled marketing capabilities where they deliver measurable value
• Managing vendors, implementation partners, contracts, and platform evaluations
• Leading change-management activities, including communication, training, adoption, and feedback management

The ideal candidate will have 5+ years of Product Management experience, ideally in B2B enterprise Marketing Technology (MarTech). They will have strong knowledge of B2B marketing and demand-generation processes, including ABM, lead management, campaigns, and attribution.

Requirements include:

• Experience with Salesforce CRM and MarTech platforms such as Marketing Cloud Account Engagement/Pardot, Demandbase, 6sense, event platforms, DAM, CMS, or similar tools
• Experience with enterprise integrations, APIs, data flows, analytics, identity/consent considerations, and third-party data sources
• Strong product strategy, roadmap, backlog management, prioritization, and Agile delivery skills
• Data-driven approach to KPIs, adoption measures, funnel metrics, attribution, and business-value targets
• Proven cross-functional stakeholder management across Marketing, Sales, Technology, Data, Privacy, Security, and Compliance

Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

XML job scraping automation by YubHub

The successful candidate will lead end-to-end contracting related to clinical, commercial, and corporate vendor contracts for products and services.

Key responsibilities include:

• Reviewing and negotiating sophisticated service agreements, Licensing, SaaS, HR & staffing agreements, and other contracts
• Leading negotiations with vendor's legal team
• Responding to and advising on legal-related requests and inquiries from business teams
• Drafting and negotiating all aspects of direct and indirect contracts
• Partnering with other departments, including Procurement, Data Privacy, and Sourcing, to support contracting matters
• Driving policy and process improvements
• Training internal employees and management on various legal matters

The ideal candidate will have:

• A JD/LLM/LLB or equivalent degree from an accredited university
• Full qualification as a lawyer
• Proven experience in a worldwide or international company
• Strong knowledge and experience in a broad range of areas of law
• Excellent communication and relationship-building skills
• Ability to work independently and as part of a cross-functional team

Syneos Health offers a dynamic and supportive work environment, opportunities for career development and progression, and a commitment to building an inclusive culture.

XML job scraping automation by YubHub

Responsibilities:

• Provide leadership and oversight of 5-20 concurrent studies depending on scope, similarity, program, and resourcing requirements
• Manage project resources, proactively alerting management of delivery and resourcing needs
• Assist with management of application vendors and serve as an initial escalation contact
• Supervise the implementations of upgrades and new modules of remotely hosted vendors
• Possess and maintain a broad overall knowledge in the field of clinical programming and clinical data management
• Contribute towards the update of standard operating procedures and work instructions
• As required, oversee program level clinical programming operations by providing supervision for a team of clinical programmers

Requirements:

• 10+ years of experience in clinical programming
• 2+ years of experience in Custom Functions Programming (Moderate to Complex)
• Experience in Rave Programming, Migration exposure, Publish Check, PPC, TSDV, Study Build programming, SDBE Rave certification
• Preferred Veeva CDMS experience

Benefits:

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture where you can authentically be yourself

XML job scraping automation by YubHub

Core Responsibilities

• Provides assistance on organizational projects and initiatives, including training, system deployments and enhancements, process development and documentation, validation activities, and data migrations.
• Participates in process improvements, such as assisting in the redesign and improvement of business processes.
• Assists in problem identification and resolution, including monitoring operational indicators, exercising critical thinking and problem-solving skills, and communicating impact.
• Provides accurate operational metrics for areas overseen by Global Operations Management, including extracting data, analyzing metrics, and communicating findings.
• Supports end-users of processes and systems, responding to questions, identifying issues for escalation, and documenting support issues.
• May assist with preparation and maintenance of end-user training materials and job aids.

Requirements

• Proven experience with SharePoint administration and content structuring.
• Hands-on experience with Power Automate and workflow creation.
• Ability to independently manage and optimize SharePoint environments.
• Experience working across systems/tools and improving processes.
• Ability to work autonomously with minimal guidance.
• Strong attention to detail and quality focus.
• Proactive, solution-oriented approach and critical thinking.
• Ability to connect processes and operate across different tasks.
• Flexible, team-oriented mindset.

XML job scraping automation by YubHub

Key responsibilities include:

• Reviewing CMC sections of regulatory submissions, as well as interactions and responses with regulatory agencies
• Working with regulatory colleagues to develop global regulatory CMC strategies and submissions
• Participating effectively on cross-functional teams and serving as the primary regulatory CMC contact for assigned products and projects

Requirements:

• Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• Typically 4 years of experience in the pharmaceutical industry or related field, or equivalent combination of education and experience
• Preferred experience supporting Small Molecule programs

Syneos Health offers a range of benefits, including:

• Company car or car allowance
• Health benefits, including Medical, Dental, and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time

The salary range for this position is $56,400.00 - $115,100.00.

XML job scraping automation by YubHub

Responsibilities:

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR
• Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans
• Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory reportability
• Maintain safety tracking for assigned activities
• Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required
• Validate and submit xEVMPD product records, including appropriate coding of indication terms using MedDRA
• Identify and manage duplicate ICSRs
• Participate in audits as required
• Foster constructive and professional working relationships with all project team members

Qualifications:

• Bachelor's degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience
• Safety Database systems and knowledge of medical terminology required
• Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet
• Ability to work independently and in a team environment
• Excellent communication and interpersonal skills, both written and spoken
• Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
• Detail-oriented with a high degree of accuracy and ability to meet deadlines

XML job scraping automation by YubHub

The successful candidate will have exposure to CMC authoring, specifically authoring CTD Module 3 (M3) sections independently, and experience with post-approval variations/supplements, cross-functional interaction with analytical, formulation, and manufacturing teams, CMC writing, and lifecycle management for small molecules.

Key Responsibilities:

• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
• Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance.
• Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned projects according to agreed timelines, scope of contract, budgets, and strategies.
• Participate as regulatory support on multidisciplinary project teams to develop products throughout their life cycle.
• Act as a subject matter expert and help team members with day-to-day troubleshooting activities, presenting solutions to project-related problems.
• Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
• Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
• Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
• Prepare training materials and share best practices in the regulatory area, both internally and externally.
• Participate as regulatory support in internal or external project audits.
• Participate as regulatory support on internal cross-functional initiatives.
• Contribute to the creation and/or maintenance of SOPs and other process-related documentation as required.
• Provide support in oversight to team members in the execution of their project responsibilities.
• Capable of identifying when to ensure line support required to provide additional guidance and direction.
• Maintenance of individual training records (Syneos Health or client-related) and completion of all designated required training.

Mandatory Skillsets:

• CMC authoring exposure, authored CTD Module 3 (M3) sections independently.
• Experience with post-approval variations/supplements.
• Cross-functional interaction with analytical, formulation, and manufacturing teams.
• CMC writing and lifecycle management for small molecules.
• Experience across: EU, USFDA, AU, GCC, ROW.

The ideal candidate will be able to:

• Own CTD sections
• Interpret technical data
• Write content from raw CMC documents
• Defend content in authority queries
• Know section numbers and expectations

XML job scraping automation by YubHub

The Pricing Systems Analyst will analyze internal and external customers' needs and identify problems and/or enhancements. This involves analyzing financial and pricing information contained in excel models and/or online pricing systems and databases.

Key responsibilities include:

• Testing updates made to Pricing Tool assumptions and algorithms and identifying required changes
• Correcting errors in assigned Pricing tools and formulating changes as required
• Collaborating and troubleshooting technical issues with the IT group and 3rd party system developers and technical specialists
• Preparing and updating user instructions and training materials
• Collaborating with Finance and Accounting to ensure timely updates to data
• Communicating departmental processes and ensuring adequate training is available
• Supporting assigned work streams associated with the ongoing support, improvement, and continued utilization of the Company’s Pricing Systems
• Tracking and managing assigned workload including delivery to timelines

Requirements:

• 1-2 years of experience in pharmaceutical or CRO industry or comparable experience in related field of study
• BA/BS or equivalent in a business or health-related degree or equivalent education and experience
• Intermediate to advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
• Above-average attention to detail, effective oral/written communication skills and problem-solving skills
• Good analytical, negotiation, and organizational skills
• Experience in Financial, Pricing and/or Business Analysis

The company offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

XML job scraping automation by YubHub

Responsibilities:

• Perform all activities related to the treatment and analysis of biological samples
• Record activities related to sample analysis and assist in verifying documents
• Initiate analytical runs using appropriate instruments and software
• Follow up on analysis results and help find solutions to bioanalytical problems
• Assist in disposing of chemical and biological waste produced by laboratory employees and help clean laboratory equipment and instruments
• Perform support tasks to meet laboratory user needs
• Ensure activities are performed in accordance with company policies, standard operating procedures, and applicable operational guides

Requirements:

• Bachelor's degree or college diploma in science
• Computer skills, particularly with Microsoft Word, Excel, and analytical software
• Basic understanding of analytical chemistry requirements
• English proficiency; bilingualism required, including comprehension of simple messages and basic instructions
• Relevant certifications may be considered acceptable

At Syneos Health, we offer opportunities for career growth, training, and recognition programs. We strive to build an inclusive culture where everyone can be themselves. Our mission is to deliver solutions that have a significant impact on patients' lives.

This is a potential opportunity rather than a currently open position. By expressing interest, you will be added to our talent pool and considered if this position materialises.

XML job scraping automation by YubHub

As a Project Supervisor, Bioanalysis – Clinical Research, you will be responsible for coordinating the entire range of activities related to the bioanalytical portion of projects to meet internal and external client expectations, and for mobilising and guiding team members.

Responsibilities

• Plan, organise, manage, and monitor activities/operations of the work unit according to expertise, work plan, and division and/or organisation needs to achieve expected results.
• Prepare, revise, and/or approve all project-related documents.
• Manage resources allocated to projects to ensure client deadlines are met.
• Provide technical expertise to laboratory personnel.
• Interact daily with the technical/scientific team and management to establish priorities for assignments.
• Communicate necessary information to keep the team and organisation informed about the team's work plan, projects, processes, results, measures taken, and recommendations made to satisfy needs.
• Inform internal/external clients about different areas of expertise in the division by assessing needs and conducting analyses and follow-ups.
• Represent the work unit internally and externally for consultation and/or information and/or references.
• Ensure team members have access to training.
• May be called upon to contribute to developing the work unit's budget and ensuring it is respected, monitoring the budget for stakeholders, and recommending measures to achieve expected results.
• Participate in developing and analysing performance indicator systems for the work unit according to established objectives.
• Identify opportunities for improving the work plan and service processes.
• Determine necessary measures to improve efficiency.
• Responsible for performing activities in accordance with company and division policies, standard operating procedures, and operational guidelines, and for performing other tasks assigned by management.

Requirements

• College diploma in sciences.
• Level of English: bilingualism required, including oral and written communication on often technical subjects, and writing technical procedures and reports.

We offer a dynamic work environment, opportunities for career growth, and a comprehensive compensation package.

XML job scraping automation by YubHub

As a Bioanalytical Data Specialist, you will be responsible for assigning samples to be analysed in the LIMS system, collaborating with relevant departments to prepare samples for analysis, and communicating any sample discrepancies to the central laboratory, site, and/or sponsor as needed.

Key responsibilities:

• Review central laboratory/site documentation to process and assign incoming samples in the LIMS system.
• Ensure study sample integrity and help resolve issues related to sample identification.
• Collaborate with sample management and laboratory leadership to ensure samples are processed and verified within analysis deadlines.
• Provide operational support for sample receipt, inventory, verification, and reconciliation.
• Archive documents associated with study sample management.
• May be required to prepare and review documents during regulatory visits.

Additional qualifications:

• Excellent communication, presentation, and interpersonal skills, both written and verbal.
• Good computer skills (Microsoft Word, Excel, and ability to use sample tracking software).
• Experience working in a regulated environment is an asset.
• French and English bilingualism is required, including understanding simple messages and following basic instructions.

Syneos Health has collaborated on 94% of new drugs approved by the FDA, 95% of products authorised by the EMA, and over 200 studies involving 73,000 sites and 675,000 patients.

XML job scraping automation by YubHub

The successful candidate will partner with HR, business leaders, and cross-functional stakeholders to translate business questions into actionable analytics, identify workforce trends, and develop scalable reporting solutions.

Key responsibilities include:

• Serving as a Subject Matter Expert (SME) for Syneos HR data, workforce metrics, systems, and reporting structures
• Conducting advanced workforce analysis across the employee lifecycle
• Developing workforce forecasts and scenario-based analyses to support hiring strategies and business decision-making
• Building, enhancing, automating, and maintaining dashboards, scorecards, and recurring reports using Power BI, Workday, Excel, and other reporting tools
• Presenting actionable insights and recommendations to HR and business leaders through effective data storytelling and visualization techniques

The ideal candidate will have:

• 5+ years of experience in HR analytics, workforce analytics, people analytics, workforce planning, or related reporting and analytical roles
• Advanced proficiency in Power BI, Microsoft Excel, and data analysis
• Strong understanding of workforce analytics, workforce planning, talent acquisition metrics, and talent management reporting
• Excellent written, verbal, and presentation skills

Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

XML job scraping automation by YubHub