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Title:Data Manager
Location:NJ - Bridgewater

Contribute to data management activities related to drug product development for assigned compounds or indications. Collaborate with internal biostatistics, Clinical Operations, and CRO data management and biostatistics.

  • Collaborate with Biostatistics and Clinical Operations on database design, edit checks, data review and data extracts.
  • Review published CRFs and hyperlinks in support of FDA, EMEA or worldwide submissions
  • Review data, definition files, and other DM or biostatistical components of a submission to ensure content meets Regulatory agency submission requirements
  • Review CRF for consistency with company standards

  • B.S. required. Preference in science or computer 2 years experience in clinical trials in a data management role
  • Excellent communication and writing skills
  • Experience with cancer clinical trials preferred
  • Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management preferred
  • Knowledge of EDC and CDISC preferred

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