TMF Support Analyst
• 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 Title: Trial Master File (TMF) Support Analyst I/ Support Analyst II/Senior Support Analyst
Reports to: Vice President of Clinical Operations/Project Leader/Project Manager/TMF Support Analyst Manager
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 isconsistent 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.
- 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
• Provide project teams with outstanding trial and data management
expertise/resources, and ensure deliverables with quality, on time, and cost-effective
• Develop strong values and foster innovations 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
Training and Education Requirements
Candidates for the position should have the following levels of experience:
- 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.