Clinical Trial Mgr to Associate Dir, Clinical Tria

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Clinical Project Manager provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and vendors.
Essential Functions of the Job (Key responsibilities)
Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.
Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
Lead the evaluation and selection of investigative sites; responsible for feasibility.
Select, coordinate and monitor activities of vendors Review of monitoring reports and conduct co-monitoring visits, as needed.
Develop and manage trial(s) timelines, budget and priorities.
Participate in data review and discrepancy resolution.
Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.
Generate reports to update management on conduct of trial.
Ensure appropriate clinical trial supply plans are implemented and managed.
Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
Participate in monitoring study safety.
Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work.
Assist with CRA and third party vendor training on protocols and practices.
Lead the multi-disciplinary trials teams; include the study team meetings.
Function as the primary contact for trial(s) between Drug Development and other departments.
Assume responsibility to participate as a member of working groups and perform special projects, as assigned.
Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS/BA degree or a relevant degree with strong emphasis on science.
Minimum of four years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
Demonstrate leadership and problem solving skills.
Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).
Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment.
Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently.
Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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Job Posting: 970857

Posted On: May 13, 2022

Updated On: Jun 12, 2022