Amgen Clinical Trial Oversight Manager in Seoul, United States

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