Amgen Clinical Site Mgmt Oversight Mgr in Shanghai, China
•Performs oversight activities of FSP staff including CTA and CRA performance, delivery and quality metrics (KPIs, report(s) metric analysis/review) in collaboration with FSP-LM
•Collaborates closely with FSP Line Manager (FSP-LM) to ensure appropriate level of oversight deployed
•Supports CTA and CRA onboarding and training
•Supervises staff involved in local site contracting and budget management, insurance and payment process
•Point of escalation to support resolution of issues eg quality, staff turnover
•Works with FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management
•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
•Participates in Functional Management Team (FMT) Meetings and applicable country-level project review meetings
•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
•Office/field based role
•Single point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, including the identification, escalation and resolution of quality and delivery issues
•Provides GSO SM functional area expertise and actively collaborates in a dynamic cross-functional environment
•Oversight of the site contracting process
•Line Manager to SCBAs
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.
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