TMF Document Specialist (TMF experience needed)

Ogłoszenie numer: 6247119, from 2022-01-13

Looking for TMF Experts!

Do you have previous Trial Master File (TMF) experience and an eye for detail?  We have an exciting opportunity to expand our TMF Operations team to ensure a complete and accurate TMFs through documentation quality and consistency across clinical trials and programs.
The Document Specialist is responsible for contributing towards making our clients’ Trial Master Files (TMF) inspection ready. Collaborating with key stakeholders, being accountable for their actions and delivering the highest quality outcome for the client.

TMF Document Specialist (TMF experience needed)

Location: lubelskie / Lublin


Job description

  • Process documents into eTMF system following guidance, to the required quality and productivity levels, across multiple clients.
  • Remap documents across TMF structures according to client-specific guidance and Company SOPs.
  • Perform Quality Review across multiple core clients, to the required quality and productivity levels.
  • Remediation of TMF to include query analysis and resolution, and ongoing TMF maintenance.
  • Archive preparation, to include inventory review and completion, tracking of paper and box handling.
  • Identify opportunities for process improvement.

With the appropriate training and experience:

  • Coach and mentor small groups of people.
  • Coordinate allocation of work across a team.
  • Use inhouse generated MI to facilitate continuous improvement in quality, productivity and other KPI’s.
  • Perform analysis of Heatmap data and provide expert advice to client on TMF health.


  • Have excellent working knowledge of Trial Master File documentation, eTMF Systems and TMF structures.
  • Excellent attention to detail and organisational skills.
  • Can work to deadlines in a fast paced environment and prioritise, multitask and reschedule tasks as appropriate.
  • Ability to make decisions independently, using a flexible approach.
  • Willingness to embrace change and work collaboratively.
  • IT experience including basic MS Office (Word, Excel).
Please add the following clause: I agree to the processing of my personal data for the needs necessary in the recruitment process.
Praca lubelskie