TMF Support Analyst

Position Purpose

  • To provide internal and external teams with outstanding TMF operational expertise and ensure deliverables with quality, on time, and cost-effective measurable services.
  • To develop strong values and foster innovations in TMF process.
  • To continuously improve performance and productivity (ensure high skill level), and provide operational excellence through best practices and lesson learned.

Position Overview
The Trial Master File (TMF) Support Analyst is the Quality Control Expert assigned to a project and will:

  • Ensure TMF and document accuracy and completeness.
  • Ensure clinical trial documentation is consistent with the Trial Master File specifications, submission/inspection readiness criteria and complies with LMK’s (or client’s) SOPs and regulatory requirements.
  • Serve as single point of contact to the TMF Project Manager or equivalent to ensure a complete and accurate TMF through documentation quality and consistency across clinical trials and programs.
  • Serve as a subject matter expert in commissioned projects.

Primary Responsibilities

  • Perform TMF and Quality Control (QC) and remediation across functional lines.
    Scan and index documentation into the eTMF.
  • Support teams during inspection or audits.
  • Ensure documents maintained in the TMF are appropriate and the content of those
    documents are accurate, complete and consistent with LMK’s (or client’s) SOPs and
    regulatory requirements.
  • Provide project teams with outstanding trial and data management
    expertise/resources, and ensure deliverables with quality, on time, and cost-effective
    measurable services.
  • Develop strong values and foster innovation in TMF implementation, maintenance
    and good documentation practices.
  • Continuously improve performance and productivity (ensure high skill level and
    performance of staff) and provide operational excellence through best practices and
    lesson learned.

Training and Education Requirements

  • Minimum of Bachelor’s Degree or equivalent.
  • Clinical Documentation Management and industry experience that have provided a thorough understanding of the processes associated with conducting a clinical trials and document management operations.
  • 1-2 years of Clinical Research experience or professional equivalent.
  • 1-2 years of Document QC experience or professional equivalent.
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