FSP Feasibility Manager

This is a fully remote position, open to applicants in Italy.

📋 Description

• Oversee strategic and operational feasibility initiatives for designated clinical studies and development programs.

• Propel evidence-based country selection by utilizing operational insights, historical data, epidemiology, and data analytics to ensure optimal study execution.

• Create and implement data-driven recruitment strategies and enrollment forecasts in partnership with Feasibility Analysts and cross-functional study teams.

• Assess country, site, and patient recruitment potential through both internal and external data sources and feasibility tools.

• Collaborate with sponsors and stakeholders from Thermo Fisher Scientific to formulate comprehensive feasibility strategies that facilitate study planning and execution.

• Establish and nurture strong collaborative relationships with Clinical Operations, Clinical Sciences, Medical Affairs, Regulatory Affairs, Clinical Supply, Country Operations, Site Activation, Epidemiology, Biostatistics, and other essential functional partners.

• Present feasibility recommendations and enrollment projections to study teams and governance groups, ensuring clear rationale and risk evaluations.

• Detect recruitment risks and suggest proactive mitigation strategies during study planning and execution.

• Aid in portfolio-level planning by offering feasibility insights across various studies and therapeutic areas as needed.

• Lead or participate in cross-functional feasibility working groups and study planning discussions.

• Act as a subject matter expert (SME) on feasibility methodologies, systems, and analytical tools.

• Assist in the evaluation, implementation, and ongoing enhancement of feasibility processes, technologies, and data analytics solutions.

• Ensure all feasibility tasks are performed in accordance with sponsor requirements, SOPs, ICH-GCP, regulatory guidelines, and Thermo Fisher Scientific quality standards.

• Contribute to initiatives aimed at process improvement that enhance the quality, efficiency, and consistency of feasibility deliverables across the FSP organization.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or a related scientific field.

• 4–7 years of experience in study feasibility.

• Experience in supporting global or regional clinical trial feasibility activities.

• Proven understanding of global clinical trial planning, country selection, site identification, and patient recruitment strategies.

• Strong knowledge of the drug development process and global clinical research regulations, including ICH-GCP and relevant regulatory guidelines.

• Familiarity with country and site feasibility methodologies, enrollment forecasting, and recruitment planning.

• Experience with clinical trial intelligence and recruitment platforms such as Citeline, TriNetX, DQS, GlobalData, or similar tools.

• Strong analytical abilities with experience in interpreting complex datasets and translating results into actionable recommendations.

• Proficiency in data visualization and reporting tools, including Microsoft Excel and PowerPoint; experience with Power BI or similar platforms is a plus.

• Outstanding verbal, written, and presentation skills with the capability to communicate effectively with both technical and non-technical audiences.

• Strong stakeholder management and influencing abilities, with the capacity to cultivate collaborative relationships across sponsor and Thermo Fisher Scientific teams.

• Excellent organizational, planning, and prioritization skills with the aptitude to manage multiple studies concurrently.

• Proven problem-solving capabilities and sound decision-making skills.

• High attention to detail with a dedication to quality and continuous improvement.

• Ability to work independently while effectively contributing within global, matrixed teams.

🏝️ Benefits

• Flexibility to support global teams across various time zones.

• Occasional travel may be necessary for business meetings, client engagements, or team events.