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Scientific. Clinical. Software Engineering

Clinical Document Specialist

Marin Metro Area, CA

Job Type: Clinical Job Number: JN -042020-26770 Region: Marin Metro Area

Job Description

Our Bay Area client is recruiting for a Clinical Document Specialist to join their growing team.


  • Act as point of contact for Study Team regarding TMF questions and manage close-out of TMF related issues in adherence to company processes
  • Participate in the Quality Control of documents submitted to the TMF or eTMF
  • Support the management of TMF documentation issues throughout the lifecycle of an assigned study
  • Provide guidance on best practices for record handling, retrieval and archival procedures
  • Participate in the development, implementation, and maintenance of internal databases used to manage records


  • Bachelor s degree in life science or related field preferred
  • 2 plus years of TMF experience with a biopharmaceutical company or CRO
  • Familiarity with GLP and GCP regulations and best practices
  • Strong organizational, communication and interpersonal skills
  • Self-motivated with ability to work with minimal guidance

**Local Candidates Only**

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