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Clinical Data Manager

New Jersey All, New Jersey

Post Date: 01/05/2017 Job ID: JN -012017-18046 Industry: Data Management - Clinical
  • Interact both verbally and through written communication with inter-organizational and outside customer contacts as well as with Central and External laboratories, CROs, etc.
  • Contribute to the design of protocols
  • Develop eCRF specifications according to protocol and approved standards (based on industry standards), participate in user acceptance testing
  • Develop protocol specific edit check specifications, participate in user acceptance testing
  • Develop and maintain project- specific Data Management plan throughout the life-cycle of the study protocol, which includes CRF annotation, database specifications, edit checks and other pertinent data management documents
  • Provide training for team members in data management procedures
  • Prioritize tasks with respect to pre-determined timelines
  • Provide direction and coordinate data management activities to ensure timely database lock and release of data for interim and final analyses
  • Provide oversight, monitor and track quality of vendor data management deliverables, ensuring audit practices are in place to validate the quality of EDC database content as well as external electronic data transfers
  • Perform metrics on data management processes and guidelines to evaluate efficiency, accuracy, and speed in cleaning clinical study data and locking database for study reporting
  • Ensure data processing activities are performed according to protocol, GCP and SOPs
  • Participate in hands-on data review and query management as necessary
Requirements:
  • Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical) and understanding of database/programming concepts preferred
  • High level of knowledge in the use of Data Management applications and database/file structures
  • Able to use SQL, SAS and other programming/query languages
  • Project Management skills
  • Experience in early phase development studies preferable
  • Bachelor degree, preferably in a life science or mathematics-related area (e.g. computer sciences)
  • 8+ years of industry experience with at least 4 years of clinical data management experience


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