TMF Excellence Lead – eTMF & Compliance

KPS Life; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

KPS Life is seeking a TMF subject matter expert to oversee end-to-end TMF processes across studies, ensuring documents are uploaded, indexed, and compliant with the EDL. The role includes maintaining TMF tools, supporting study teams in Veeva, and driving timely issue resolution.

Qualified candidates bring 6+ years in pharma/clinical research with TMF experience, strong Excel/Veeva skills, and a proven ability to generate TMF metrics and dashboards for inspection readiness.

Qualifications

• Bachelor’s degree in life sciences or health-related field.
• 6+ years in pharma/clinical research with TMF/compliance focus.
• Extensive experience with eTMF systems (Veeva preferred).
• Experience generating TMF metrics, dashboards, KPIs.

Responsibilities

• Oversee TMF processes: upload/index/classify documents per TMF Plan/EDL.
• Maintain sponsor TMF tools/templates (TMF Plan, TMF Index, TMF Rules).
• Prepare TMF Index and EDL for study milestones in Veeva.
• Track documents against EDL; identify gaps and file promptly.
• Escalate non-compliance; drive issue resolution with stakeholders.
• Create TMF metrics and dashboards; support monthly/quarterly reporting.
• Perform TMF risk-based quality checks and report findings.

Skills

TMF knowledge

Veeva eTMF

Excel data analysis

Quality assurance

Education

Bachelor’s degree in life sciences/health

Tools

Veeva

Pivot tables in Excel

Job description

KPS Life is seeking a TMF subject matter expert to oversee end-to-end TMF processes across studies, ensuring documents are uploaded, indexed, and compliant with the EDL. The role includes maintaining TMF tools, supporting study teams in Veeva, and driving timely issue resolution.

Qualified candidates bring 6+ years in pharma/clinical research with TMF experience, strong Excel/Veeva skills, and a proven ability to generate TMF metrics and dashboards for inspection readiness.