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Senior TMF Specialist

  • Job type: Permanent
  • Location: San Rafael, California
  • Salary: US$80000 - US$120000 per year
  • Job reference: 217471/001_1541103262
  • Sector: Compliance, Selby Jennings
  • Date posted: 01/11/2018

SUMMARY DESCRIPTION

Are you interested in Process Transformation and becoming part of a team that is leading and developing TMF strategies and best practices? We are looking for a Sr. TMF Specialist who can partner with our trial team and quality team stakeholders, to advise and consult on best practices for future clinical studies. Would you be interested in leading the TMF team and developing the teams expertise? Look no further.

KEY RESPONSIBILITIES:

TMF Quality and Records Management/ eTMF Management

  • Facilitate the creation of the enterprise and study specific TMF management tools

  • Maintain TMF Management Plans and TMF Content Lists for complex studies; work with the Study Teams to check and verify the plans and communicate the importance of each document to the Study Team based on risk level

  • Coordinate creation of the TMF filing locations within company based on the study specific TMF Content List

  • Manage Quality Control of documents (paper and electronic) submitted to the TMF or eTMF

  • Facilitate the review and submission of TMF records to Records Management personnel

  • TMF-Related Collaboration & Support

  • Support the coordination of the transfer of study-specific trial master files from the CRO

  • Participate in Study Team meetings and provide/present regular TMF metrics updates

Comprehensive Review

  • Conduct quality review of the TMF for each assigned study on an annual basis per the time points captured in the study-specific TMF Plan

  • Establish any corrective actions which must be addressed and assigned

  • Submit documented evidence of the TMF Quality Review to the TMF

  • Manage TMF documentation issues throughout the lifecycle of an assigned study

Records Management

  • Participate in the implementation of standards and processes for DevSci records management to verify compliance with relevant regulations

  • Support and carry out the processes associated with the storing, archiving, indexing, scanning and classifying records:

    • Process records (e.g., track, scan, archive) in compliance with DevSci Records SOPs

    • Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records in DevSci Records

    • Provide guidance on best practices for record handling, retrieval and archival procedures

EDUCATION AND EXPERIENCE

  • BA/BS in life sciences or technical area; experience in lieu of education may be considered

  • 4+ years of relevant pharmaceutical industry experience

  • Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus