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Clinical Data Manager - United States
Posted on : 19 June 2017
The Clinical Data Manager is responsible for performing 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 to ensure that a quality work product is produced and timelines and deliverables are met.
- Participate as the primary data management representative on company multidisciplinary project teams and ensure effective communication exchange
- Perform ongoing data review, including reconciliation of third party data streams and serious adverse event reconciliation with the safety database.
- Perform User Acceptance Testing (UAT) of clinical databases.
- Perform Quality Control (QC) of clinical databases.
- Generation and maintenance of data management related documentation
- If applicable, overseeing that the Contract Research Organizations (CROs) utilized by company Corporation (IC) perform data management activities in accordance with ICH/Good Clinical Practices (GCP).
- Other duties, as assigned
- A minimum of 3-5 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 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.