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Lead Data Manager

New Jersey All, New Jersey

Post Date: 01/25/2017 Job ID: JN -012017-18196 Industry: Data Management - Clinical
  • Oversee the management of clinical trial databases from study start up to study closure
  • Review protocol synopsis and attend protocol review meetings as the subject matter expert
  • Lead CRF Design and author or review CRF completion guidelines
  • Develop or lead in the review of a Data Management Plan
  • Develop and test edit specifications
  • Ensure coding has been performed and reviewed by Medical Coder
  • Perform external data reconciliation, provide data management related metrics and provide specific data listings
  • Trouble-shoot database issues with DBA
  • Perform database lock and freeze activities
  • Prepare and present data collection requirements at Investigator Meetings
  • Participate in CRO selection
  • Review SOWs for data management activities and costs in contracts
  • Participate in regular team meetings and provide input when appropriate
  • Interact with physicians, scientists, monitors, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
  • Assist in database upgrades/migrations including performing User Acceptance Tests
  • Serve as the DM representative on clinical project teams that are developing NDAs
  • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of 5 years of experience as a Lead Data Manager
  • Must be a Senior Level person with experience in leading and managing all DM related deliverables on multiple trials for both in sourced and outsourced trials
  • Proficient in RAVE

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