Clinical Trial Oversight Manager
Amgen Inc.
Shanghai, China
3天前

Responsibilities :

  • Primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues
  • Provides support of clinical study execution
  • Provides GSO-SM functional area expertise and actively collaborates in a dynamic cross-functional environment
  • Oversight of the site contracting, budgeting and payment process
  • Line Manager of SCBAs
  • Key Activities :

    Performs sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis / review), to ensure quality and delivery of Amgen clinical trials.

  • Collaborates closely with SM-FSP Line Manager (FSP-LM) to ensure appropriate level of their staff oversight is deployed.
  • Supports SM-FSP staff onboarding and training
  • Supervises staff involved in local site contracting and budget management, insurance and payment process
  • Manages SCBA onboarding and training
  • Point of escalation for all stakeholders to support resolution of issues egquality, staff turnover and performance concerns
  • Works with SM-FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out
  • Conducts on-site quality visits with CRAs where / when appropriate and supports the maintenance of Amgen investigator site relationships
  • Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
  • Organizes and leads the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable.
  • Involved in local and global site management and cross-functional stakeholder collaboration
  • Actively participates in role forums including local and global functional and cross-functional initiatives
  • Join Us

    If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

    Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

    As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win.

    Together, we live the Amgen values as we continue advancing science to serve patients.

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