Tmf Support Analyst Jobs

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 Associate is the Quality Control Expert assigned to a project and will:

• Serve as a subject matter expert in commissioned projects.
• 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.
• 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.
• Ensure TMF and document accuracy and completeness.

Primary Responsibilities

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

Training and Education Requirements

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