TMF Lead: Veeva Vault eTMF Expert

BioSpace; Malvern (Chester County); On-site; USD 110,000 - 160,000; Full time

Job summary

Ocugen is seeking a TMF Lead to own Trial Master Files across assigned studies, ensuring completeness, quality, and inspection readiness within the Veeva Vault eTMF system.

You will work with Clinical Operations, Regulatory Affairs, Data Management, and CROs to implement TMF plans, monitor KPIs, and drive CAPAs. The role requires strong TMF experience, regulatory knowledge, and independent judgment in a small biotech environment.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree is a plus.
• 5-7 years of clinical research experience with strong TMF operations focus.
• Hands-on TMF management from startup to closeout, including Veeva Vault eTMF.
• Working knowledge of TMF RM/EDL and regulatory requirements (ICH-GCP, FDA/EMA/MHRA).
• Experience supporting sponsor audits/inspections and CRO/vendor oversight.

Responsibilities

• Lead TMF activities across studies, ensuring completeness and inspection readiness in Veeva Vault.
• Serve as SME for TMF questions and coordinate with Clinical Operations, Regulatory, and CROs.
• Develop TMF management plans, EDL configurations, and monitor TMF metrics and KPIs.
• Perform TMF QC, identify gaps, and drive CAPAs with root-cause analysis.
• Coordinate document retrieval and responses during audits/inspections; lead remediation.

Skills

Veeva Vault eTMF expertise

TMF lifecycle management

Cross-functional collaboration

Regulatory inspection readiness

SOP development

Education

Bachelor's degree in life sciences

Advanced degree a plus

Tools

Veeva Vault eTMF

CTMS

EDC/RTSM

Job description

Ocugen is seeking a TMF Lead to own Trial Master Files across assigned studies, ensuring completeness, quality, and inspection readiness within the Veeva Vault eTMF system.

You will work with Clinical Operations, Regulatory Affairs, Data Management, and CROs to implement TMF plans, monitor KPIs, and drive CAPAs. The role requires strong TMF experience, regulatory knowledge, and independent judgment in a small biotech environment.