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Precision Medicine Group
TMF Lead
Remote · Serbia · Senior level
About the role
The TMF Lead supports project teams to maintain high quality Trial Master Files in compliance with GCP and company SOPs. The role involves managing complex studies and mentoring junior TMF Leads.
What you’ll do
• Ensure timely, high-quality TMF document review and maintenance. • Create and execute study TMF Plan and Document Index. • Attend project meetings and communicate TMF status. • Identify and mitigate TMF compliance risks. • Support audits and provide TMF expertise to sponsors.
What you’ll bring
• Bachelor's degree or equivalent experience. • 5+ years related experience. • Knowledge of FDA & ICH/GCP regulations. • Strong organizational and communication skills. • Legal authorization to work without sponsorship.
About Precision Medicine Group
Precision Medicine Group specializes in healthcare and medical research services, focusing on clinical trial management and compliance.