Feasibility Manager (m/f) - Anywhere, EU Office-based or Remote-based Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. Position Overview The Feasibility Manager (FM) is responsible for performing feasibility analysis of clinical trials to assess the study plan and provide feedback and recommendations, including the identification of potential challenges and mitigating strategies. Responsibilities include compiling feasibility reports, presentations, and sample site assessment for investigator feedback on study design and logistics, as well as enrollment potential. Responsibilities
- Study Review – Review clinical protocols, study assumptions, client information and study plans for Europe and global trials.
- Research, compile and analyze information on therapeutic area(s) contained in the clinical protocol. This may include any or all of the following: incidence, prevalence, standard of care, factors determining and influencing indication frequency and distribution, treatment trends, competing trials, etc., and use this information to provide an overall assessment of the feasibility of the study plan.
- Interface with consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
- Design site surveys/questionnaires to obtain key information (e.g., investigator feedback on projected enrollment, feasibility of the study, and site capabilities); may assist in the identification/selection of sample sites. Oversee the site information collection process and assess compiled information for trends and site capabilities.
- Provide input to proposals and business development to help build project assumptions, budget, and timelines.
- Participate in strategy meetings with internal and external groups.
- Provide feasibility reports and feasibility presentations.
- Present and explain feasibility analysis to BD/Clients, including the process, recommendations and rationale.
- Some experience as an Research Specialist, FM, PM, CRA or CTA is required.
- A minimum of 3 years experience in the conduct of clinical trials is required.
- Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Proficiency in Microsoft Word, Excel, and PowerPoint, Outlook.
- Strong verbal and writing skills; English + local language, if relevant.