Clinical Trial Oversight Manager

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 (FSPLM)

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 eg quality, 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 crossfunctional

stakeholder collaboration

• Actively participates in role forums including local and

global functional and cross-functional initiatives.