Sr. Clinical Data Coordinator
The Sr. Clinical Data Coordinator is responsible for performing activities related to clinical database development, data review and maintenance of specific data management documentation pertaining to the conduct of Phase I â€“ III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.
- Perform User Acceptance Testing (UAT) of clinical databases.
- Perform Quality Control (QC) of clinical databases.
- Perform ongoing data review, including reconciliation of third party data streams and serious adverse event reconciliation with the safety database.
- Perform ongoing updates of Data Management-related documentation, as needed.
- A minimum of 3 years of data management experience is required.
- A 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 Informâ„¢ EDC system is preferred. Oncology and/or inflammatory therapeutic area experience is preferred.
Incyte Corporation - 2 years ago