Catalyst Clinical Research is hiring a
Feasibility Manager

Summary

Join our team as a Feasibility Manager and contribute to producing feasibility proposals and reports, setting priorities, and ensuring data source integrity.

Requirements

• Education: Master’s or PhD in a scientific field (or comparable advanced scientific/clinical degree, such as PharmD)
• Experience: Must have 3 years relevant experience in drug development with 2-4 years experience in conducting the following: pre-award feasibility, post-award site identification / site selection / recruitment planning for global studies
• Excellent written and verbal communication skills
• Ability to work independently, prioritize and work in a team environment is essential
• Experience using external Clinical Trial Databases (e.g. Informa Citeline, TriNetX, PubMed/Medline, ClinicalTrials.gov , BioPharm Clinical, etc.), governmental, and public databases or related experience with research databases
• High data analysis competency and ability to develop and implement complex models using MS Excel and standalone platforms
• Ability to research and review scientific literature, study reports, medical journals to identify and represent current clinical trial landscape considerations in verbal and written format

Responsibilities

• Research, compile and analyze therapeutic area(s) information contained in the clinical protocol
• Collects and analyzes metric-based global intelligence for pre-award strategic clinical trial development
• Collaborates with medical experts on trial conduct, proposed therapy acceptance and standard of care in target regions
• Responsible for recruitment rate & enrollment data verification, country and site distribution development, proposal text generation, meeting proposal timelines, and contributing towards bid defense material for presentations and independent feasibility assessments
• Conducts independent standalone site outreach projects as required
• Interacts with sites, clients, vendors, consortiums, advocacy groups and other functional areas as secondary project contact for site issues and questions
• Study Review – Review clinical protocols, study assumptions, client information and study plans for US and global trials
• Provide input to proposals and business development activities to help build project assumptions, budget, and timelines
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations and rationale in verbally and within written formats (e.g. MS Word or MS Powerpoint)
• Manages time and project requirements based on study contract
• 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 study sites
• Arranges the post award hand over to Site Activation Manager (SAM)