Clinical Documentation Director

San Francisco, California
September 16, 2025
$145 / hour
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Job Description

Job Summary:

  • Responsible for the strategic leadership, management, control, storage, and compliance of the clinical trial master file (TMF) and supporting documents from set-up through archival.
  • The individual will develop records maintenance standards including the system(s) for management and archival, implementation and maintenance for managing clinical trial information and transition of all
  • TMFs into a central eTMF.
  • The individual will manage the Clinical Documentation Group, which oversees the management of the Trial Master File, authoring, review, and approval of Trial Master File (TMF) plans and other TMF process documents, TMF quality reviews, development of TMF/eTMF process documents and standards, vendor management and oversight, supporting internal and external audits and inspections.
  • Develop and implement a TMF compliance and quality strategy through creation and management of TMF governance, training, quality checks, metrics, and key performance indicators.
  • Lead TMF gap assessments, audits, assessments, and inspections.
  • As a subject matter expert in Veeva Vault eTMF, serve as Client Veeva Vault eTMF Business Administrator (Client Vault).
  • Provide TMF system and administration support to business users within the R&D organization for various study TMFs hosted within Client and by the CROs (NextDocs, Veeva Vault, Trial Interactive, etc.).
  • Develop and maintain Client TMF procedures, policies, and work instructions ensuring adherence to business standards and all applicable regulations and guidelines.

Education:

  • Bachelor’s Degree or equivalent.

Required Skills & Experience:

  • 10+ years of clinical trial experience with 8+ years specifically in TMF.
  • 3+ years of experience as Veeva Vault Administrator.
  • Expertise in TMF compliance, quality strategy, gap assessments, and inspections.
  • Strong knowledge of clinical trial document management systems (NextDocs, Veeva Vault, Trial Interactive).
  • Ability to develop and maintain TMF procedures, policies, and work instructions.
  • Strong leadership skills managing Clinical Documentation Group.
  • Experience in supporting internal and external audits and inspections.
  • Proficiency in providing system administration support within eTMF environments.

Preferred Skills & Experience:

  • Subject matter expert in Veeva Vault eTMF.

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