Job DescriptionHow You'll Contribute:The Veeva eTMF Document Specialist is responsible for the management, quality control, and completeness of clinical trial documentation within the electronic Trial Master File (eTMF), with a focus on Veeva Vault. This role ensures that all essential documents are accurate, complete, and inspection-ready in compliance with ICH/GCP guidelines, regulatory requirements, and company SOPs. The position works cross-functionally with Clinical Operations, to support efficient trial execution and audit readiness.
What You'll Do:Management & Oversight
- Maintain the eTMF within Veeva Vault, ensuring all documents are filed accurately and in the correct structure.
- Perform ongoing TMF quality reviews (completeness, timeliness, accuracy, and consistency) in partnership with Study Management.
- Track document status and follow up with study teams to resolve gaps.
Document Processing & Quality Control
- Review clinical documents for quality, metadata accuracy, and regulatory compliance prior to filing.
- Ensure documents meet ALCOA+ principles.
- Perform QC checks on documents uploaded by internal teams.
- Assist with creation of eTMF Plans and eTMF Index in partnership with Study Management.
Inspection Readiness & Compliance
- Support audit and inspection readiness activities.
- Generate TMF reports, metrics, and dashboards.
- Identify trends and escalate compliance risks.
Cross-Functional Collaboration
- Partner with Clinical Trial Assistants, CRAs, Study Managers, Data Management and Biostatics .
- Provide guidance and training to study teams.
Collaborate with Study Teams to ensure TMF alignment.
How You'll Get There:Bachelor's degree in Life Sciences or related field preferred.
- 2-5+ years clinical trial or TMF experience.
- Experience with Veeva Vault eTMF required.
- Key Competencies
- Attention to detail
- Accountability
- Collaboration
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