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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. Job Responsibilities Participate as the primary data management representative on Incyte 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 Incyte Corporation (IC) perform data management activities in accordance with ICH/Good Clinical Practices (GCP). Other duties, as assigned Minimum Requirements 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.
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