What are the responsibilities and job description for the TMF Specialist position at Viridian Therapeutics, Inc?
At Viridian, we work with a sense of urgency for patients, creating unity with our team, the industry, and the community. We are committed to using proven science and engineering to improve the lives of people living with serious and rare diseases and we are getting closer to achieving this goal every day.
Reporting to the Associate Director, Records Management, the TMF Specialist, will be responsible for working across clinical study teams in line with TMF processes across the development portfolio, with regards to the TMF Review, filing and maintenance activities for clinical studies during the study start-up, maintenance and close-out periods. The TMF Specialist will manage and maintain the Trial Master File (TMF) to ensure compliance with regulatory and company standards. This role involves organizing, tracking, and auditing TMF documents to support clinical trial operations. The TMF Specialist collaborates with cross-functional teams to ensure the accuracy, completeness, and timely filing of essential documents.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
- Maintain and oversee the electronic Trial Master File (eTMF) system, ensuring completeness, accuracy, and compliance with regulatory requirements (ICH-GCP, FDA, EMA, MHRA, etc.).
- Responsible for Sponsor eTMF review and assess eTMF metrics for completeness, timeliness, and quality.
- Work closely with Clinical Operations, and other stakeholders to ensure proper TMF maintenance and alignment with study timelines.
- Identify and address discrepancies or missing documents in the TMF, coordinating with relevant teams for resolution.
- Provide support to the Records Management Team for audits and regulatory inspections, ensuring the file is up to date and organized for easy retrieval of documents.
- Perform the TMF QC processes, including both individual document quality checks and TMF completeness reviews.
- Support Records Management group in day-to-day activities, as applicable.
