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TMF Operations Manager
2 months ago
We are seeking a highly skilled TMF Operations Manager to join our team at The RFT Group. As a key member of our Clinical Development and Operations group, you will be responsible for managing Trial Master Files (TMFs), Sponsor Oversight Files (SOF), and archiving for all studies according to ICH-GCP and other regulatory requirements.
Key Responsibilities- Manage TMFs, SOFs, and archiving for all studies, ensuring compliance with ICH-GCP and other regulatory requirements.
- Work closely with Clinical Project Managers across Phase I-III trials, covering multiple responsibilities of outsourced operational activities.
- Line manage, coach, and develop TMF Specialists.
- Provide vendor oversight (CROs, etc.) for Clinical Study operational activities.
- Present study tracking and progress reporting to CTMs and Leadership team.
- Bachelor of Science degree preferred.
- 7+ years' experience managing TMFs in Clinical Operations environment, in the pharmaceutical, biotech, or CRO industry working 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.
- Experience in QC, maintenance of trial tracking sheets and databases, and preparing documentation for archiving.
- Proven ability to work under pressure to meet project deadlines.
- Exposure to Veeva Vault and other document management systems, e.g., Docusign, etc.
- 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.
