Local Study Operations Line Sr. Manager
Amgen
August 26, 2026
Remote friendly (United States)
United States
Operations
Local Study Operations Line Sr. Manager
Responsibilities
- Lead skill development of Local Study Operations Managers (LSOMs) to ensure effective country trial implementation aligned with global strategies.
- Oversee delivery of the country study portfolio (scope, timelines, budgets) through LSOM leadership.
- Partner with the Country GSSO Head to foster an optimal clinical research environment supporting global R&D objectives.
- Drive alignment and continuous improvement in LSOM execution via best practices, digital innovation, and knowledge sharing.
- Ensure successful delivery from feasibility through study close-out.
- Monitor portfolio progress; provide risk and quality oversight; support issue escalation/resolution.
- Manage LSOM and LSOM vendor performance; serve as primary escalation point for local study challenges.
- Mentor, train, and support LSOM professional development for complex trials.
- Build and maintain a high-performing team; facilitate collaboration with study strategy and local study teams; promote cross-functional collaboration across country teams.
- Support study placement decisions based on country capabilities and growth potential.
- Evaluate risks, quality trends, and resource needs; implement mitigation and continuous improvement.
- Lead initiatives to enhance operational efficiency and share best practices.
- Manage resource allocation/workload distribution across LSOMs (FSP and FTE) to optimize execution and align with global priorities.
- Ensure adherence to applicable regulatory and quality standards.
- Collaborate with the country head to engage cross-functional stakeholders, align on deliverables, and manage escalations.
Qualifications
Basic
- Doctorate + 2 years clinical execution experience OR Master’s + 6 years OR Bachelor’s + 8 years OR Associate’s + 10 years OR High school/GED + 12 years.
- Plus at least 2 years managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.
Preferred
- 7 years life sciences/medically related experience, incl. 4 years biopharmaceutical clinical research on clinical trials (biotech/pharma/CRO).
- Experience managing multiple teams/direct reports across clinical functions/trials.
- Experience with clinical research vendors (CROs, central labs, imaging, etc.).
- Experience managing clinical operations across region with strong knowledge of local regulatory requirements.
Benefits
- Total Rewards Plan (eligible): employee benefits including Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending; discretionary annual bonus or sales incentive (field); stock-based long-term incentives; time-off plans; flexible work models where possible.
Application instructions
- Apply now via careers.amgen.com. No application deadline; applications accepted until a sufficient number are received or a candidate is selected.
Responsibilities
- Lead skill development of Local Study Operations Managers (LSOMs) to ensure effective country trial implementation aligned with global strategies.
- Oversee delivery of the country study portfolio (scope, timelines, budgets) through LSOM leadership.
- Partner with the Country GSSO Head to foster an optimal clinical research environment supporting global R&D objectives.
- Drive alignment and continuous improvement in LSOM execution via best practices, digital innovation, and knowledge sharing.
- Ensure successful delivery from feasibility through study close-out.
- Monitor portfolio progress; provide risk and quality oversight; support issue escalation/resolution.
- Manage LSOM and LSOM vendor performance; serve as primary escalation point for local study challenges.
- Mentor, train, and support LSOM professional development for complex trials.
- Build and maintain a high-performing team; facilitate collaboration with study strategy and local study teams; promote cross-functional collaboration across country teams.
- Support study placement decisions based on country capabilities and growth potential.
- Evaluate risks, quality trends, and resource needs; implement mitigation and continuous improvement.
- Lead initiatives to enhance operational efficiency and share best practices.
- Manage resource allocation/workload distribution across LSOMs (FSP and FTE) to optimize execution and align with global priorities.
- Ensure adherence to applicable regulatory and quality standards.
- Collaborate with the country head to engage cross-functional stakeholders, align on deliverables, and manage escalations.
Qualifications
Basic
- Doctorate + 2 years clinical execution experience OR Master’s + 6 years OR Bachelor’s + 8 years OR Associate’s + 10 years OR High school/GED + 12 years.
- Plus at least 2 years managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.
Preferred
- 7 years life sciences/medically related experience, incl. 4 years biopharmaceutical clinical research on clinical trials (biotech/pharma/CRO).
- Experience managing multiple teams/direct reports across clinical functions/trials.
- Experience with clinical research vendors (CROs, central labs, imaging, etc.).
- Experience managing clinical operations across region with strong knowledge of local regulatory requirements.
Benefits
- Total Rewards Plan (eligible): employee benefits including Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending; discretionary annual bonus or sales incentive (field); stock-based long-term incentives; time-off plans; flexible work models where possible.
Application instructions
- Apply now via careers.amgen.com. No application deadline; applications accepted until a sufficient number are received or a candidate is selected.