Study Oversight Senior Manager
Amgen
August 21, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Study Oversight Sr Mgr
Responsibilities:
- Manage all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and compliance adherence.
- Serve as secondary contact and escalation point for FSP supplier-related concerns within the country.
- Mentor, train, and support professional development of SOM Mgr.
- Serve as point of contact for FSP supplier resource/capacity management, portfolio planning, and prioritization from study startup to close-out.
- Ensure oversight of supplier performance (tracking against metrics; assuring quality of work).
- Identify, escalate, and resolve quality and trial delivery issues.
- Collaborate with LSOM Senior Managers and/or LSOM AD to ensure appropriate staff oversight and maintain quality throughout Amgen clinical trials (including occasional on-site quality visits).
- Drive consistent communication between SOM Mgr, FSPs, and sites; ensure alignment with global strategies.
- Escalate issues to the County-Hub Head GSSO.
- Aggregate and communicate country-wide issues; provide country-aggregated view on FSP trends/challenges to senior management.
- Oversee FSP supplier performance for study milestone achievement and quality targets.
- Support inspection readiness; support local country site audits and regulatory inspections when applicable.
- Support maintenance of Amgen investigator site relationships in country.
- Participate in cross-functional task forces/process improvement groups.
Basic Qualifications:
- Doctorate + 2 years clinical execution OR Master’s + 6 years OR Bachelor’s + 8 years OR Associate’s + 10 years OR High school/GED + 12 years.
- Plus minimum 2 years experience directly managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.
Preferred Qualifications:
- 7 years life sciences/medically related experience, including 4 years biopharmaceutical clinical research on clinical trials (biotech/pharma/CRO).
- Experience managing multiple teams/direct reports across clinical functions/trials.
- Experience overseeing clinical research suppliers (CROs, central labs, imaging, etc.).
- Experience managing clinical operations across region; strong understanding of local regulatory requirements for global clinical trials.
Benefits (Total Rewards highlights):
- Competitive health/welfare plans, retirement/savings plan, life/disability insurance, flexible spending accounts; discretionary bonus; stock-based long-term incentives; time-off plans and company shutdowns; flexible work/remote arrangements where possible.
Application Instructions:
- Apply via careers.amgen.com.
Responsibilities:
- Manage all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and compliance adherence.
- Serve as secondary contact and escalation point for FSP supplier-related concerns within the country.
- Mentor, train, and support professional development of SOM Mgr.
- Serve as point of contact for FSP supplier resource/capacity management, portfolio planning, and prioritization from study startup to close-out.
- Ensure oversight of supplier performance (tracking against metrics; assuring quality of work).
- Identify, escalate, and resolve quality and trial delivery issues.
- Collaborate with LSOM Senior Managers and/or LSOM AD to ensure appropriate staff oversight and maintain quality throughout Amgen clinical trials (including occasional on-site quality visits).
- Drive consistent communication between SOM Mgr, FSPs, and sites; ensure alignment with global strategies.
- Escalate issues to the County-Hub Head GSSO.
- Aggregate and communicate country-wide issues; provide country-aggregated view on FSP trends/challenges to senior management.
- Oversee FSP supplier performance for study milestone achievement and quality targets.
- Support inspection readiness; support local country site audits and regulatory inspections when applicable.
- Support maintenance of Amgen investigator site relationships in country.
- Participate in cross-functional task forces/process improvement groups.
Basic Qualifications:
- Doctorate + 2 years clinical execution OR Master’s + 6 years OR Bachelor’s + 8 years OR Associate’s + 10 years OR High school/GED + 12 years.
- Plus minimum 2 years experience directly managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.
Preferred Qualifications:
- 7 years life sciences/medically related experience, including 4 years biopharmaceutical clinical research on clinical trials (biotech/pharma/CRO).
- Experience managing multiple teams/direct reports across clinical functions/trials.
- Experience overseeing clinical research suppliers (CROs, central labs, imaging, etc.).
- Experience managing clinical operations across region; strong understanding of local regulatory requirements for global clinical trials.
Benefits (Total Rewards highlights):
- Competitive health/welfare plans, retirement/savings plan, life/disability insurance, flexible spending accounts; discretionary bonus; stock-based long-term incentives; time-off plans and company shutdowns; flexible work/remote arrangements where possible.
Application Instructions:
- Apply via careers.amgen.com.