TMF Record Specialist

Job description

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 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.