Sr. TMF Lead

📋 Description

• Lead TMF oversight for studies and programs.
• Ensure TMF quality, compliance and inspection readiness.
• Partner with PM and functional leads on TMF deliverables and risks.
• Deliver TMF oversight reports and status updates on cadence.
• Lead study-level audit and inspection readiness activities.

🎯 Requirements

• 7–9 years TMF CRO experience with Bachelor's degree.
• ICH-GCP, 21 CFR Part 11, EU CTR knowledge.
• TMF Reference Model and risk-based TMF management.
• Experience with TMF inspection readiness and audits (FDA/EMA/MHRA).
• Experience with leading eTMF platforms (Veeva Vault, Wingspan).
• Strong stakeholder management and client-facing skills.

🎁 Benefits

• Global cross-functional TMF team environment.
• Career growth and development opportunities.
• Mentorship and training programs.
• Exposure to regulatory inspections and audits.
• Flexible remote collaboration and work arrangements.
• Competitive benefits package.