eTMF Business Analyst - Remote

Job Summary

We are seeking a Veeva Vault eTMF Business Analyst to support the management, monitoring, and continuous improvement of Trial Master File (TMF) quality and compliance. The ideal candidate should have strong experience with Veeva Vault eTMF, TMF Reference Model, document quality oversight, completeness reviews, and TMF metrics reporting.

The role requires close collaboration with Clinical Operations, TMF Operations, CROs, Quality Assurance, and Study Teams to ensure inspection-ready Trial Master Files throughout the study lifecycle.

Key Responsibilities

• Monitor overall TMF health across active clinical studies.
• Perform TMF completeness and quality reviews using Veeva Vault eTMF.
• Track expected versus actual TMF documents and identify missing or overdue artifacts.
• Review document metadata for completeness and accuracy.
• Monitor document lifecycle status and ensure timely approvals.
• Generate and analyze TMF metrics, including:
• TMF Completeness
• Timeliness
• Quality Index
• Document Filing Compliance
• Expected Document Status
• Missing Documents
• Overdue Documents
• Conduct periodic TMF health checks and provide recommendations for improvement.
• Coordinate with study teams and CRO partners to resolve TMF quality issues.
• Prepare inspection readiness dashboards and study health reports.
• Support sponsor and regulatory inspection readiness activities.
• Track TMF KPIs and prepare weekly/monthly management reports.
• Participate in TMF governance meetings and provide metric updates.
• Assist in defining TMF business requirements for system enhancements.
• Perform User Acceptance Testing (UAT) for new Vault eTMF features and configurations.
• Create functional documentation, SOPs, and work instructions.
• Train end users on TMF processes and Veeva Vault eTMF functionality.

Required Skills

• Strong experience with Veeva Vault eTMF
• Thorough understanding of the TMF Reference Model
• Knowledge of ICH-GCP and regulatory requirements related to TMF
• Experience with TMF completeness and quality management
• Strong understanding of expected document management
• Experience creating TMF dashboards and reports
• Excellent analytical and problem-solving skills
• Experience working with cross-functional clinical teams
• Strong communication and stakeholder management skills

Preferred Skills

• Experience with Veeva Vault Reports and Dashboards
• Knowledge of Clinical Operations processes
• Familiarity with CTMS integrations
• Experience with inspection readiness activities
• Basic SQL, Excel, or Power BI reporting skills
• Experience with Veeva Vault configuration or validation is an advantage

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or a related field.
• 3–8 years of experience in Clinical Operations, TMF Operations, or Veeva Vault eTMF.
• Experience supporting global clinical trials.
• Strong understanding of GxP, ICH-GCP, and TMF Reference Model.