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.