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Clinical Trial Manager
2 months ago
Job Summary
We are seeking a highly skilled Clinical Trial Manager to lead and manage the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulations.
Key Responsibilities
- Country Strategy and Study Progress
Partner with global and local country teams to provide high-level country strategy and actively drive study progress and local/country-level study delivery.
Clinical Study ExecutionPlan, manage, and oversee clinical study execution in line with the global program strategy, through leadership with engagement of the cross-functional Local Study Team (LST).
Regulatory ComplianceCompile 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 AssuranceConduct 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., li>
Site Contracting and BudgetingCoordinate site contracting, budgeting, insurance, and payment process by supervising local support roles.
Team LeadershipAssign and lead all aspects of deliverables of study support staff and continually review country-level risk mitigation to ensure study delivers to plan.
CommunicationTriage/tailor communication from study/local team to sites to ensure efficient and effective communication flow.
Requirements
- Leadership Experience
Experience of leading local/regional or global teams within a Biotech, Pharmaceutical, or CRO company.
Clinical Research ExperienceWork experience in biopharmaceutical clinical research acquired working on clinical trials.
Vendor ManagementExperience in management and oversight of external vendors (e.g., li>
Clinical Trial Project ManagementLocal/country expert with proven clinical trial project management experience.
Site RelationshipsAble to build strong site relationships as well as other local relationships to ensure end-to-end study delivery is met.
Work Environment
Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next-generation workspace.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
