TMF Lead: Expert in Vault eTMF & Inspection Readiness

BioSpace; Malvern (Chester County); On-site; USD 120,000 - 150,000; Full time

Job summary

Ocugen seeks a TMF Lead to assure quality, completeness, and inspection readiness of Trial Master Files across studies using Veeva Vault. You will collaborate with Clinical Operations, Data Management, Regulatory Affairs, Pharmacovigilance, QA and CROs to meet ICH-GCP and regulatory requirements.

The role requires independent work in a small biotech, prioritizing TMF deliverables and maintaining inspection readiness through audits and remediations.

Qualifications

• Bachelor's degree in life sciences or related field.
• 5-7 years of clinical research experience with TMF focus.
• Hands-on TMF management across study lifecycle with Veeva Vault (required).

Responsibilities

• Lead TMF activities across studies from startup to closeout and archive in Veeva Vault.
• Serve as TMF SME and point of contact for study teams and CROs/vendors.
• Develop TMF management plans and EDL configurations; monitor TMF metrics and KPIs.

Skills

TMF expertise

Veeva Vault

Regulatory compliance

Quality Assurance

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Tools

Veeva Vault eTMF

Job description

Ocugen seeks a TMF Lead to assure quality, completeness, and inspection readiness of Trial Master Files across studies using Veeva Vault. You will collaborate with Clinical Operations, Data Management, Regulatory Affairs, Pharmacovigilance, QA and CROs to meet ICH-GCP and regulatory requirements.

The role requires independent work in a small biotech, prioritizing TMF deliverables and maintaining inspection readiness through audits and remediations.