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Clinical Data Manager

New Jersey All, NJ

Posted: 10/09/2018 Job Type: Clinical Job Number: JN -102018-22781
  • Perform QC of CRO activities to include Query management, Data review, DM documentation such as edit checks, lock process, etc.
  • Monitor progress of data management activities by CROs
  • Participate in regular team meetings and provide input when appropriate
  • Interact with CRAs, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
  • Regularly reconcile the Safety database to the EDC database
Skills/Knowledge Required:
  • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of three years experience as a data manager, or equivalent, in a pharmaceutical/CRO setting
  • Advanced knowledge of Excel and MS Visual Basic required
  • Knowledge of Medical Affairs helpful
  • Experience in Hematology and or Oncology
  • Proficient knowledge of EDC databases, preferably Medidata RAVE
  • Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
  • Proficiency in regulatory guidelines, agencies, GCP, etc.

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