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TMF Manager
2 months ago
About the Role:
The RFT Group is seeking a highly skilled TMF Manager to join our BioPharmaceutical Division. As a TMF Manager, you will play a critical role in managing Trial Master Files (TMFs) for clinical trials, ensuring compliance with ICH-GCP and regulatory requirements.
Key Responsibilities:
- Manage TMFs, Sponsor Oversight Files (SOF), and archiving for all studies
- Work closely with Clinical Project Managers to organize and execute clinical trial activities
- Liaise with multiple stakeholders, including investigational site staff, regarding end of trial archiving requirements
- Schedule meetings and manage travel arrangements
- Participate in team meetings, including cross-functional team meetings and meetings with third-party vendors
- Attend and participate in company audits or regulatory inspections as required
Requirements:
- Bachelor of Science degree preferred
- 7+ years' experience managing TMFs in a Clinical Operations environment, in the pharmaceutical, biotech, or CRO industry, working with ICH/GCP guidelines
- Experience in both paper and electronic TMF, and familiarity with naming and filing conventions and the CDISC TMF Reference Model and applicable industry guidelines
- Proven ability to work under pressure to meet project deadlines
- Excellent communicator of technical and scientific information
- Excellent interpersonal skills, strong organization skills, and time management skills
- Strong attention to detail required
- Proficient in Word, Excel, and PowerPoint