Clinical Trial Oversight Manager, South East Asia

5 days ago

Singapore Amgen Full time

**Key Responsibilities**
- Performs sponsor oversight activities of Functional Service Provider (FSP), including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials.
- Collaborates closely with FSP Line Manager to ensure appropriate level of their staff oversight is deployed.
- Supports FSP staff onboarding and training
- Supervises staff involved in local site contracting and budget management, insurance and payment process as a line manager
- Point of escalation for all stakeholders to support resolution of issues e.g. quality, staff turnover and performance concerns
- Works with 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 regular meetings with FSP 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

**Qualifications**
- Bachelor’s Degree or the equivalent (BSc is preferred)
- Broad work experience working in life sciences or medically related field, including clinical trial site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company
- Experience in people management or project management role at regional level in SEA and Taiwan in clinical trials
- Experience working with or for FSP or Contract Research Organizations
- Experience of contract and budget negotiation and management

**Knowledge**
- Familiarity with advanced concepts of clinical research
- Extensive knowledge of ICH/GCP regulations and guidelines, and local regulations in SEA and Taiwan
- Strong knowledge of clinical trial operations
- Understanding of FSP operational model
- Relevant therapeutic area education and training

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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