at Incyte Corporation in Wilmington, Delaware, United States
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 Senior Clinical Trial Manager provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, functions as the primary liaison for internal stakeholders and vendors leads multidisciplinary departments initiatives, and provides support for process changes to increase efficiency in study executions.
Essential Functions of the Job (Key responsibilities)
Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.
Mange the conduct of clinical Trial(s) and provide operational leadership within an outsourced, CRO model.
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.
Manage the evaluation and selection of investigative sites.
Select, coordinate and monitor activities of CRO and associated vendors.
Review of monitoring reports and conduct co-monitoring visits, as needed.
Develop and manage trial(s) timelines, budget and project milestones.
Participate in data management activities, including data review and discrepancy resolution.
Ensure set up and maintain all systems that implement trial(s) and track progress throughout the duration of the program.
Generate necessary reports to update leadership on conduct of trial.
Ensure appropriate clinical trial supplies are ordered in time and supply plans are implemented and managed.
Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
Participate in monitoring study safety.
Develop key study quality metrics (e.g., protocol deviations per site; number of queries per site, number of SOP deviation for the study, number of data base migrations 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 the Clinical Scientist, Medical Monitor, CRA and other third party vendor training on protocols and practices.
Lead the multi-disciplinary teams in operational 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, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS/BA degree or a relevant degree with strong emphasis on science.
Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.
Able to manage complex and/or large trials.
Demonstrated ability to manage complex and/or large trials in an outsourced, CRO model a plus.
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, critical thinking, time management 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... For full info follow application link.
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