Related skills
gcp etmf veeva vault tmf sponsor oversight📋 Description
- Serve as primary eTMF contact for studies; address questions promptly.
- Manage QC/complete TMF documents per GCP and regulatory rules.
- Collaborate with CROs/partners on TMF activities; monitor KPIs and EDLs.
- Provide TMF guidance to study teams per established processes.
- Support TMF training; contribute to WIs, SOPs, and tools.
- Support TMF elements of regulatory inspections with relevant docs.
🎯 Requirements
- BSc in biomedical, life science, or related field.
- 4+ years in TMF operations for clinical studies.
- Proficiency with TMF, GCP, and eTMF systems (Veeva Vault).
- TMF experience at sponsor company (not CRO).
- Knowledge of DIA TMF reference model and cross-functional processes.
- Experience with Veeva eTMF: uploading, reviewing, QC, and approvals.
🎁 Benefits
- Competitive benefits package.
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to Operations Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!