Clinical Document Specialist II

How 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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