TMF Lead & SME — eTMF Mastery for Trials

Ocugen; Malvern (Chester County); On-site; USD 90,000 - 130,000; Full time

Job summary

Ocugen seeks a TMF Lead to own TMF activities from study startup through closeout, ensuring completeness, quality, and inspection readiness in the Veeva Vault system. You will collaborate across Clinical Operations, Data Management, Regulatory Affairs, and QA to drive TMF excellence and regulatory compliance.

The role requires hands-on TMF management, CAPA implementation, and audit support in a fast-paced biotech environment. Strong cross-functional communication is essential.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree a plus.
• 5-7 years of progressive clinical research experience with TMF operations focus.
• Hands-on experience with Veeva Vault eTMF system (required).
• Knowledge of DIA TMF RM and EDL management; regulatory familiarity.
• Experience supporting sponsor audits/regulatory inspections and TMF remediation.
• CRO/vendor management experience; independent, cross-functional partner.

Responsibilities

• Lead TMF activities across studies from startup to closeout and archival in Veeva Vault.
• Serve as TMF SME and primary resource for study teams and CROs/vendors.
• Develop TMF management plans, filing strategies, and EDL configurations.
• Conduct TMF QC reviews, self-inspections, risk identification, CAPAs.
• Maintain inspection readiness; coordinate responses for audits/inspections.
• Ensure compliance with ICH-GCP, FDA/EMA/MHRA, and SOPs governing TMF.
• Configure and administer Veeva Vault eTMF for studies; manage access/roles.
• Collaborate with Clinical Ops, CRAs, CROs to ensure timely filing of documents.
• Provide TMF training and guidance; lead TMF-related meetings.
• Track TMF workload and KPIs; elevate risks and resource constraints.
• Contribute to TMF SOPs and best-practice documentation; vendor onboarding.
• Independently prioritize TMF deliverables across multi-study portfolio.

Skills

TMF operations

Veeva Vault

Regulatory knowledge

Audit readiness

Cross-functional

SOP compliance

Education

Bachelor's degree in life sciences

Advanced degree a plus

Tools

Veeva Vault eTMF

CTMS

EDC

RTSM

Job description

Ocugen seeks a TMF Lead to own TMF activities from study startup through closeout, ensuring completeness, quality, and inspection readiness in the Veeva Vault system. You will collaborate across Clinical Operations, Data Management, Regulatory Affairs, and QA to drive TMF excellence and regulatory compliance.

The role requires hands-on TMF management, CAPA implementation, and audit support in a fast-paced biotech environment. Strong cross-functional communication is essential.