More jobs:
Associate Director, TMF Operations
Job in
Columbus, Franklin County, Ohio, 43224, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Healthcare
Healthcare Compliance
Job Description & How to Apply Below
Associate Director, TMF Lead, responsible for developing and executing Kyverna's in-house Trial Master File strategy to ensure inspection readiness and regulatory compliance across clinical studies.
Responsibilities:- lead end-to-end TMF setup and governance
- oversee document quality
- manage TMF lifecycle from start-up to close-out
- lead migration efforts
- evaluate and select TMF system vendors (notably Veeva Vault)
- support regulatory audits
- Collaborate closely with Clinical Operations, Regulatory, Quality, and IT teams to ensure seamless document flow and compliance.
- Bachelor's in life sciences or related field
- 10+ years in clinical research with extensive TMF expertise, including strategic oversight, hands-on management, and transition from outsourced to in-house models
- deep knowledge of TMF structures, document taxonomy, and regulatory standards (FDA, EMA, ICH-GCP)
- proven experience with Veeva Vault and TMF migration projects
- biotech or cell/gene therapy experience preferred
Remote eligible; reports to Sr. Director, Clinical Operations.
Position Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×