Position Summary
The Feasibility Manager, Site ID (FM, Site ID) is responsible for development and oversight of collaborative relationships with internal departments to conduct and ensure delivery of high-quality feasibility/site identification assessments.
This includes conducting feasibility surveys and participating in intelligence gathering to coordinate feasibility projects and deliverables according to contractual obligations.
The FM, Site ID is working independently, and must demonstrate strong communication and leadership skills, good attention to detail, good time management and organizational skills as well as commitment to quality.
Strong analytical skills are a pre-requisite to the job to allow FM, Site ID to fully adopt a consistent data-driven approach to feasibility and site identification.
In addition, FM, Site ID will support Operational Strategy and PSN teams as needed.
They will play an important role in setting and achieving department goals, and as part of the Operational Strategy Department, will contribute and support colleagues in the achievement of company goals.
Essential functions of the FM, Site ID job include but are not limited to:
Site identification and implementation of feasibility projects, including standalone feasibility work:
Leading and/or contributing to internal planning meetings, training calls, client KOM and interim client teleconferences.
Collaboration on the development of initial site list development (initial site prioritization).
Ensuring accuracy / quality of survey data, including review and QC of departmental deliverables at all stages of the feasibility conduct.
Overseeing and analysis of project status to ensure successful completion of milestones, timelines, and deliverables.
Working with team to identify potential risks and out of scope activity; discussing contingency plans with strategist and/or PM; identifying risk trends across projects.
Assisting in the development of the feasibility budget in the instance of a budget modification.
Management of feasibility hours / budget for assigned projects.
Managing and leading the process of clinical Feasibility planning to support the proposal and project teams, including, but not limited to:
Study Review – Review clinical protocols, study assumptions, client information and study plans for US and global trials
Researching, compiling and analysis of 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.
Interfacing with consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
Providing input to Operational Strategy, proposals, and business development to help build project assumptions, budget, and timelines.
Participating in strategy meetings with internal and external groups.
Providing feasibility reports and feasibility presentations.
Presenting and explaining feasibility analysis to BD/Clients, including the process, recommendations and rationale.
Development of best practices for feasibility conduct.
Ensuring compliance with departmental training plans and required SOPs.
May serve as a “buddy” to new hires.
Providing input on the development of future systems/releases.
Managing and support of PSN, Operational Strategy, proposal and project teams as a technical Feasibility expert.
Qualifications
Minimum Required:
Bachelor’s degree or equivalent and relevant formal academic / vocational qualification.
Previous clinical research experience, including background in feasibility, that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years
Preferred
Master’s degree in a life science, communication and/or scientific discipline is strongly preferred
Other Required
Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
Excellent organizational and communication skills with computer proficiency (at a minimum Excel, MS PPT)
Professional use of the English language; both written and oral
Ability to travel approximately 20% for business needs.
Competencies
Strong judgment and decision-making skills
Strong analytical skills in reviewing data to make effective decisions
Strong project management skills as shown through management of multiple projects, with cross-functional and client interaction
Strong oral and written communication skills
Strong interpersonal, problem solving and conflict resolution skills
Strong leadership skills
Proven ability to manage multiple projects simultaneously
Strong computer skills
Attention to detail
Ability to work both in a team and independently
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