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Sr, Clinical Data Manager

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 03/26/2019 Job Type: Clinical Job Number: JN -032019-24432
One of our Bay Area diagnostics clients is recruiting for a Sr Clinical Data Manager to join their growing team.

Summary:
  • Function as Lead Data Manager for assigned projects and act as the primary point of contact for clinical data management issues for assigned components
  • Create and/or oversee creation of data management documentation for assigned projects, including the Case Report Form (CRF), Data Management Plan (DMP), and clinical database specifications
  • Use knowledge of database management to define clinical database requirements
  • Perform user acceptance testing of clinical database and edit checks
  • Manage data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely manner as part of the study team
Requirements:
  • Bachelor's degree with 5 years of experience in clinical data management
  • Familiarity with regulatory and ICH-GCP guidelines applicable to data management
  • Ability to work with clinical database software (i.e.: Medrio, Oracle Clinical, Medidata RAVE, Inform, etc.)
  • Ability to collaborate across departments and interact with various levels in the organization
  • Comprehensive understanding of the clinical study process.
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