Study Planning and Feasibility Manager
Remote throughout Europe
The Study Planning & Feasibility Manager within the Clinical Development; Strategic Business Operations group is responsible for Study Mobilization, Country and Site feasibility, and Enrollment Planning activities in support of clinical studies.
This position oversees the framework to ensure study planning and feasibility standards, processes, and KPIs are met or exceeded. It supports clinical teams in conducting rapid, accurate, and robust assessments of program and protocol feasibility, focusing on data-driven estimates, benchmarking, scenario development, and precise planning for clinical trial delivery.
Reporting Relationships:
- Reports to: Associate Director, Study Operations
- Direct reports: Study Planning and Feasibility Specialist. Management may include contract staff via staffing agencies, CROs, or FSPs.
Main Responsibilities and Accountabilities:
- Ownership of the Study Mobilization process, establishing standards and managing the initiation of study planning and feasibility activities, including data-driven assumptions from protocol to feasibility completion.
- Support and maintain the feasibility process, documenting changes across study phases, and partnering with Clinical Operations to ensure rapid, accurate assessments and milestone planning.
- Involve stakeholders to develop realistic enrollment plans and ensure their needs are considered.
- Review and implement tools to streamline feasibility processes.
- Manage Enrollment Planning, providing initial timelines, budgets, country footprint, and assumptions, and ensuring effective scenario planning.
- Provide timely enrollment status reports and oversee tools like Study Optimizer for planning and reporting.
- Facilitate knowledge sharing and process standardization across study teams to reduce start-up times.
- Uphold professional standards and industry best practices, maintaining current knowledge of Study Operations and regulatory considerations.
- Lead, manage, and develop direct reports as applicable.
Education:
- Minimum undergraduate degree in business, life sciences, pharmacy, or related health/medical field preferred.
- Other degrees/certifications considered if relevant to clinical research experience.
Essential Experience:
- At least 6+ years’ relevant clinical research experience in the pharmaceutical industry.
- Understanding of drug development, feasibility, study start-up, and business operations.
- Knowledge of ICH GCP guidelines.
- Strategic planning, operational execution, and analytical skills.
- Ability to work independently and in multicultural, cross-functional teams.
Desired Attributes:
- Postgraduate qualifications.
- Proficiency in MS Project.
- Experience overseeing global clinical trials.
Competencies:
- Leadership and teamwork skills, ability to manage multiple projects, problem-solving, decision-making, and strong communication skills.
Working Relationships:
- Internal: VPs, directors, study teams, and departments like clinical services and quality assurance.
- External: MD investigators, clinical staff, CROs, consultants.
Travel requirements:
Domestic and international travel possible.
About Advanced Clinical:
Advanced Clinical is committed to improving the clinical research experience across the drug development journey, aiming to enhance lives touched by clinical research with foresight, character, resilience, and innovation.