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Clinical Trial Manager
2 months ago
We are seeking a highly skilled Clinical Trial Manager to join our team at Amgen SA. As a key member of our clinical operations team, you will be responsible for leading and managing clinical trials from start to finish, ensuring timely delivery and budget execution.
Key Responsibilities- Study Strategy and Planning
Develop and implement country-level study strategies in collaboration with global and local teams.
Study Execution and OversightPlan, manage, and oversee clinical study execution in line with the global program strategy, through leadership and engagement of the cross-functional Local Study Team (LST).
Regulatory Compliance and SubmissionsCompile and submit submissions to ethics committees/councils within the country/ies, as well as submissions relating to other aspects country needs such as, European Union Clinical Trials Regulation (EU CTR), In Vitro Diagnostic Medical Devices Regulation (IVDR) directives, etc.
Quality Assurance and Site ManagementConduct on-site quality visits with CRAs where/when appropriate and support the maintenance of Amgen investigator site relationships.
Regulatory Agency Inspection ReadinessImplement regulatory agency inspection readiness activities (e.g., monitoring plan, study specific training documents).
Site Contracting and BudgetingCoordinate site contracting, budgeting, insurance, and payment process by supervising local support roles.
Team Leadership and Risk MitigationAssign and lead all aspects of deliverables of study support staff and continually review country-level risk mitigation to ensure study delivers to plan.
Communication and Stakeholder ManagementTriage/tailor communication from study/local team to sites to ensure efficient and effective communication flow.
Requirements- Experience of leading local/regional or global teams within a Biotech, Pharmaceutical, or CRO company.
- Work experience in biopharmaceutical clinical research acquired working on clinical trials.
- Experience in management and oversight of external vendors (e.g., CROs, etc.).
- Local/country expert with proven clinical trial project management experience.
- Able to build strong site relationships as well as other local relationships to ensure end-to-end study delivery is met.