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TMF Record Specialist

Város:  Budapest
Szakterület:  Természettudományok, Kutatás
Tapasztalati szint:  1-3 év

 Join the professional team of the 120-year-old Gedeon Richter Plc., a leading pharmaceutical company in Hungary and the region!

Gedeon Richter is looking for a committed and experienced professional for the position

TMF Record Specialist

on a fixed-term basis.

Your responsibilities will be

  • Maintain TMF documentation in accordance with ICH-GCP, regulatory requirements, and internal SOPs
  • Perform quality control (QC) checks and TMF reviews to ensure completeness and accuracy
  • Collaborate with clinical research associates, project managers, and other team members to collect and reconcile documentation
  • Assist in TMF metrics reporting and contribute to continuous improvement initiatives
  • Archival of the TMF for clinical trials
  • May contribute to non-trial projects as assigned

You bring to our team

  • Bachelor’s degree in Life Sciences, Health Sciences, or related field
  • Minimum 2 years of experience in TMF management within the pharmaceutical or CRO industry
  • Strong understanding of ICH-GCP and TMF reference models
  • Experience with electronic TMF systems (eTMF)
  • Excellent organizational skills and attention to detail

We offer

  • Great opportunity for professional development in an innovation driven department
  • Great reputation at a well established pharmaceutical firm
  • Stability and a trustworthy workplace
  • Extensive benefits Package (Cafeteria)
  • Various sport and health opportunities
  • Excellent work life balance

The Richter community is looking forward to your application.

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