TMF Record Specialist

TMF Record Specialist

on a fixed-term basis.

Responsibilities

• 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

Requirements

• 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

What 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.

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