Join the professional team of the 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

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.