Study Planning & Feasibility Manager
Global Biotech | Rare Diseases | Remote Europe (UK or Italy Preferred)
In partnership with Advanced Clinical
Overview
A leading global biotech organisation specialising in Rare Diseases is seeking an experienced Study Planning & Feasibility Manager to join the Clinical Development Strategic Business Operations team.
This role is responsible for leading study planning, country and site feasibility, enrollment forecasting, and study mobilisation activities across global clinical programs. The successful candidate will play a key role in delivering data-driven feasibility strategies that support efficient study start-up, optimized recruitment planning, and successful trial execution.
Working closely with Clinical Operations, CROs, and cross-functional stakeholders, the Study Planning & Feasibility Manager will drive rapid and accurate protocol feasibility assessments, enrollment modelling, and operational planning across international studies.
This is a fully remote opportunity within Europe, with preference for candidates based in the UK or Italy.
Key Responsibilities
- Lead and manage Study Mobilisation, feasibility, and enrollment planning activities across global clinical studies.
- Develop and maintain study planning standards, processes, and KPIs to support efficient trial delivery.
- Build data-driven study assumptions from protocol development through feasibility and study start-up.
- Conduct protocol and country feasibility assessments using:
- Benchmarking and historical study data
- Recruitment and enrollment analytics
- Competitive landscape assessments
- Epidemiology and prevalence data
- EMR, claims, and patient funnel analyses
- Support country selection and site feasibility activities using defined ranking and performance criteria.
- Develop enrollment forecasts, recruitment timelines, country footprint strategies, and scenario planning models.
- Provide regular enrollment reporting and updated projections based on actual study performance.
- Partner with Clinical Operations and study teams to improve feasibility, recruitment, and start-up processes.
- Oversee the use of Study Optimizer and other enrollment forecasting tools.
- Identify operational risks and support mitigation and escalation activities where required.
- Collaborate with global cross-functional teams, CROs, and external stakeholders to ensure realistic and achievable study plans.
- Maintain awareness of industry trends, regulatory requirements, and best practices within study operations and feasibility.
Required Experience & Qualifications
Essential
- Minimum 6+ years of clinical research experience within pharmaceutical, biotech, or CRO environments.
- Strong understanding of:
- Clinical development processes
- Study feasibility and start-up
- Enrollment planning and forecasting
- Clinical operations and business processes
- Experience supporting global clinical trials.
- Strong analytical, strategic planning, and operational execution skills.
- Thorough knowledge of ICH-GCP and global clinical research regulations.
- Experience working within cross-functional and international teams.
- Ability to manage multiple priorities and complex operational decisions.
Preferred
- Bachelor’s degree in Life Sciences, Pharmacy, Business, or related healthcare discipline.
- An advanced degree or postgraduate qualification is preferred.
- Experience within Rare Diseases strongly preferred.
- Experience with enrollment forecasting and study planning systems/tools.