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 Manager, Clinical Data Management performs activities pertaining to the conduct of Phase I - III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. The Manager ensures to deliver assigned trials on time, within budget, and with highest achievable quality.
Essential Functions of the Job (Key responsibilities)
Responsible for line management of a limited number of direct reports.
Develop key CDM-related quality metrics across assigned program(s) and determine appropriate actions in conjunction with management.
Review and manage trial priorities from a data management perspective and provide data management input into timelines and documents that contribute to overall study budgets.
Work with Head of CDM to ensure appropriate resourcing to support all trials within assigned clinical program(s).
Contribute to the ongoing development, review and revisions of CDM-related Standard Operating Procedures (SOPs).
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.
Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered.
Minimum of 7 years of data management experience is required.
Experience with Electronic Data Capture (EDC) system(s) is required.
Experience with Oracle Inc.'s Inform EDC system is preferred.
Oncology and/or inflammatory therapeutic area experience is preferred.
Project management experience (within Data Management) is preferred.
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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We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.