Global Feasibility Manager
Amgen
Full-time
Remote friendly (United States)
United States
Clinical Research and Development
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Role Summary
Global Feasibility Manager
Responsibilities
- Lead activities pertaining to country and site identification, feasibility and country selection within a clinical study
- Partner with study team members, data analytics team and country teams to design and conduct global feasibility activities on time with high quality delivery
- Ensure consistency of feasibility execution across the portfolio/pipeline including bridging gaps between local/central data
- Ensure clear timelines and expectations are aligned and communicated between data providers and study teams to expedite data insight deliverables and confirm the analysis timeline is coordinated with study team decision milestones
- Confirm the Global Feasibility Strategy includes relevant data insights
- Lead the collection of local internal and external data to define an optimal geographic country footprint and proposed sites for participation in a clinical study
- In partnership with internal partners, synthesize, interpret and integrate data and information to provide clear feasibility recommendations to embed data-driven decision making
- Drive operational readiness (funding status, resourcing triggers)
- Facilitate the study baseline commitment & change process (country and study levels)
- Initiate and lead global feasibility continuous improvement efforts and initiatives
- Support development of systems, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility (country, site)
Qualifications
- Basic Qualifications:
- Doctorate degree OR
- Master’s degree & 2 years of directly related experience or equivalent, OR
- Bachelor’s degree & 4 years of directly related experience or equivalent, OR
- Associate’s degree & 8 years of directly related experience or equivalent, OR
- High school diploma / GED & 10 years of directly related experience
- Preferred Qualifications:
- M.D., D.O., PhD, PharmD, Master’s Degree
- 10+ years’ work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience
- Feasibility experience and/or Country clinical operations experience
- Understands how data and analytics can inform study design and operational planning
Skills
- Feasibility strategy development
- Data synthesis and interpretation
- Cross-functional collaboration
- Project management and process improvement
- Operational readiness and resourcing