Local Study Operations Manager (LSOM)
Amgen
2 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Local Study Operations Manager (LSOM)
What You Will Do / Responsibilities
- Lead, manage, and coordinate clinical trials at a country level from study start-up to close-out (CSR/Archival) in accordance with ICH-GCP and applicable local regulations.
- Maintain quality and scientific integrity of clinical trials locally.
- Collaborate with cross-functional internal and external partners to ensure timely delivery and budget implementation.
- Partner with global and local country teams to drive country strategy and study progress.
- Plan, manage, and oversee clinical study implementation per global program strategy via the Local Study Team.
- Communicate country status (timelines and results) to key partners and update relevant systems for transparency.
- Provide input into the Country Operational Plan; partner with Development Feasibility Manager and Global Clinical Managers to ensure local delivery.
- Support internal audit/inspection activities; contribute to CAPAs and lead issue resolution when appropriate (e.g., vendor management).
- Assign and deliver study support staff; continually review country-level risk mitigation to ensure delivery to plan.
Basic Qualifications (Required)
- Doctorate degree, or
- Master’s degree + 3 years clinical trial project management experience, or
- Bachelor’s degree + 5 years clinical trial project management experience, or
- Associate’s degree + 10 years clinical trial project management experience, or
- High school diploma/GED + 12 years clinical trial project management experience.
Preferred Qualifications
- BA/BS/BSc
- 2–3+ years leading local/regional or global teams
- 2–3+ years clinical trial project management experience
- 7+ years life sciences/medically related experience, including 4 years biopharmaceutical clinical research on clinical trials (biotech/pharma/CRO)
- Experience managing/overseeing external vendors (e.g., CROs, central labs, imaging vendors)
- Local/country expert with identifiable local project management experience
- Ability to build strong site and local relationships for end-to-end study delivery.
Benefits (Total Rewards)
- Comprehensive employee benefits package (Retirement and Savings Plan with company contributions; medical/dental/vision; life/disability; flexible spending accounts)
- Discretionary annual bonus (or sales-based incentive for field sales)
- Stock-based long-term incentives
- Time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work where possible
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications continue until a sufficient number are received or a candidate is selected.
What You Will Do / Responsibilities
- Lead, manage, and coordinate clinical trials at a country level from study start-up to close-out (CSR/Archival) in accordance with ICH-GCP and applicable local regulations.
- Maintain quality and scientific integrity of clinical trials locally.
- Collaborate with cross-functional internal and external partners to ensure timely delivery and budget implementation.
- Partner with global and local country teams to drive country strategy and study progress.
- Plan, manage, and oversee clinical study implementation per global program strategy via the Local Study Team.
- Communicate country status (timelines and results) to key partners and update relevant systems for transparency.
- Provide input into the Country Operational Plan; partner with Development Feasibility Manager and Global Clinical Managers to ensure local delivery.
- Support internal audit/inspection activities; contribute to CAPAs and lead issue resolution when appropriate (e.g., vendor management).
- Assign and deliver study support staff; continually review country-level risk mitigation to ensure delivery to plan.
Basic Qualifications (Required)
- Doctorate degree, or
- Master’s degree + 3 years clinical trial project management experience, or
- Bachelor’s degree + 5 years clinical trial project management experience, or
- Associate’s degree + 10 years clinical trial project management experience, or
- High school diploma/GED + 12 years clinical trial project management experience.
Preferred Qualifications
- BA/BS/BSc
- 2–3+ years leading local/regional or global teams
- 2–3+ years clinical trial project management experience
- 7+ years life sciences/medically related experience, including 4 years biopharmaceutical clinical research on clinical trials (biotech/pharma/CRO)
- Experience managing/overseeing external vendors (e.g., CROs, central labs, imaging vendors)
- Local/country expert with identifiable local project management experience
- Ability to build strong site and local relationships for end-to-end study delivery.
Benefits (Total Rewards)
- Comprehensive employee benefits package (Retirement and Savings Plan with company contributions; medical/dental/vision; life/disability; flexible spending accounts)
- Discretionary annual bonus (or sales-based incentive for field sales)
- Stock-based long-term incentives
- Time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work where possible
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications continue until a sufficient number are received or a candidate is selected.