Global Feasibility Manager

Role Summary

Global Feasibility Manager responsible for developing and executing the feasibility strategy for clinical studies in partnership with the clinical program team, global study management, and cross-functional data teams. Leads the feasibility process, including strategy plans, country selection, site identification, timelines, and synthesis of feasibility insights, to expedite cycle times across assigned programs. Focuses on delivering data-driven recommendations to optimize geographic footprint and site participation.

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. This includes initial enrollment timelines, footprint optimization, developing key assumptions, and establishing patient recruitment strategy potential, etc.
• Confirm the Global Feasibility Strategy includes relevant data insights and/or appropriate engagement from the Enrollment Lab, to support the successful operational execution of the Diversity Action Plans (where appropriate).
• Lead the collection of local internal and external data (e.g. local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, operational barriers) 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 further embed data-driven decision making, analyze trends, identify root causes, and provide actionable recommendations across study teams and programs to accelerate study execution.
• Drive operational readiness (funding status, resourcing triggers)
• Facilitate the study baseline commitment and 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) as well as the timing of key recruitment achievements.

Qualifications

• Required: Doctorate degree OR Master’s degree with 2 years of directly related experience or equivalent, OR Bachelor’s degree with 4 years of directly related experience or equivalent, OR Associate’s degree with 8 years of directly related experience or equivalent, OR High school diploma / GED with 10 years of directly related experience
• Preferred: M.D., D.O., PhD, PharmD, Master’s Degree
• Preferred: 10+ years’ work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, or CRO company
• Preferred: Feasibility experience and/or Country clinical operations experience
• Preferred: Understands how data and analytics can inform study design and operational planning