Job Summary (Primary function)
The Clinical Data Manager 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 CDM ensures, from a data management perspective, assigned trials on time, within budget, and with highest achievable quality.
Essential Functions of the Job (Key responsibilities)
- Participate as the primary data management representative on Incyte multidisciplinary project teams and ensure effective communication exchange.
- Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and aging, etc.) and determining appropriate actions in conjunction with study team.
- Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines.
- Participate in User Acceptance Testing (UAT), as needed.
- Participate in Quality Control (QC), as needed.
- Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines.
- Assist with site and/or third party vendor training on CDM-related topics.
- Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s).
- Perform data review and discrepancy resolution, as needed.
- Responsible for archiving trial(s) and associated documentation upon trial(s) completion.
- Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Minimum of 5 years of data management experience is required.
- 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.
- 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.
- Work history at a Clinical Research Organization (CRO) or CRO management experience in 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.
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