Feasibility Manager - Catalyst Clinical Research LLC : Job Details

As the 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. You will be responsible for setting priorities for workload and deliverables, ensuring collection of input from and coordination of activities with all stakeholders in the feasibility process and collating information with Catalysts experience to produce recommendations for country and site selection strategies. You will assure data source integrity, proper interpretation and resulting strategy provided in feasibility proposals and reports. You will participate in internal meetings and represent Catalyst at bid defense opportunities.

Position Accountabilities/Responsibilities:

+ Research, compile and analyze therapeutic area(s) information contained in the clinical protocol. This may include assessment of any or all of the following: global and regional incidence and prevalence, standards of care, factors determining and influencing indication frequency and distribution, study phase and design considerations, treatment trends, competing trials, etc., and use this information to provide an overall assessment of the feasibility of the study plan and propose potential alternatives

+ 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. Incorporate medical review of the protocol and challenges to enrollment and the retention of subjects.

+ 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)

Supervisory Requirements/ Responsibilities: Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, performance appraisals, goal setting, & salary.

Position Qualifications and Requirements:

Education: Masters 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.

Required Skills:

+ 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.

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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