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Manager Clinical Records Mgt.

San Francisco Metro Area, California

Post Date: 08/18/2017 Job ID: JN -082017-19836
Responsibilities:
  • Develops and leads the Clinical Trial Master File (TMF) lifecycle process across functional departments and other stakeholders to drive standardization, harmonization and implementation of TMF/eTMF management and archival policy globally
  • Responsible for ensuring complete and accurate TMFs through consistency and application or adoption of documented TMF procedure(s)
  • Works with study vendors and CROs to ensure TMF is accurate and complete by assessing vendor TMF on an ongoing basis
Requirements:
  • Bachelor s degree desired
  • Minimum of 8 years of experience working directly with Trial Master Files and associated clinical documentation with overall 10+ years of pharmaceutical industry experience

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