Feasibility Manager

4 days ago

Raleigh, North Carolina, United States Catalyst Clinical Research, LLC Full time
Job Title: Feasibility Manager

Catalyst Clinical Research, LLC is seeking a highly skilled Feasibility Manager to join our team. As a Feasibility Manager, you will be responsible for producing feasibility proposals and reports for pre-award business development activities and post-award for ongoing studies as required.

Key Responsibilities:
  • Research and analyze therapeutic area information contained in clinical protocols to provide an overall assessment of the feasibility of the study plan and propose potential alternatives.
  • Collect and analyze metric-based global intelligence for pre-award strategic clinical trial development.
  • Collaborate with medical experts on trial conduct, proposed therapy acceptance, and standard of care in target regions.
  • Responsible for recruitment rate and 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.
  • Conduct independent standalone site outreach projects as required.
  • Interact 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.
  • Manage time and project requirements based on study contract.
  • Design site surveys/questionnaires to obtain key information and may assist in the identification/selection of study sites.
  • Arrange the post-award handover to Site Activation Manager (SAM).
Supervisory Responsibilities:

The position will have management responsibilities, including development, oversight, and direction of departmental staff, which may include interviewing, terminations, training, personal growth, retention plans, performance appraisals, goal setting, and salary.

Requirements:
  • Master's or PhD in a scientific field or comparable advanced scientific/clinical degree.
  • 3 years of relevant experience in drug development with 2-4 years of experience in conducting 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.
  • Experience using external Clinical Trial Databases, 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.
Working Conditions:

General office working conditions apply. Employee may be office or home-based.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.

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