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Senior Clinical Data Associate

San Mateo Metro Area, CA

Posted: 01/10/2019 Job Type: Clinical Job Number: JN -022019-23712
One of our biopharmaceutical clients is recruiting for a Senior Clinical Data Associate to join their growing team.

Overview:
  • Perform all data management tasks as appropriate including data review and query management to ensure that quality standards are achieved
  • Perform reconciliation of the clinical database against safety data, laboratory data and other third party data
  • Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and Data Review Guidelines and raise queries to resolve incomplete data
  • Interact with other project team members to support the set-up, maintenance, and closure (e.g., Database Lock) of the Data Management aspects of the project and attend meetings as required
  • Actively participate in eCRF Screen Review meetings
  • Filing of data management documentation
Education and Experience:
  • Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field
  • 4 years plus of relevant work experience in data management with a biotech, pharmaceutical or CRO
  • Good understanding of pharmaceutical industry, clinical trial development/drug development and the role of data management
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines
  • Prior experience with detailed documentation processes
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