TMF Lead II (LATAM)

The role

The TMF Lead II supports project teams in maintaining high quality Trial Master Files in accordance with GCP, guidance documents, and Precision SOPs. This role supports a range of studies across the Precision Medicine Group portfolio.

What you will do

• Ensure TMF document review, processing, quality review, set up, maintenance, finalization and archival is completed timely and with high quality
• Create and execute the study TMF Plan and project TMF Document Index
• Ensure TMF documentation is filed in the TMF
• Attend and contribute to project meetings to ensure team awareness of TMF status, gaps and escalations
• Collaborate with Project Manager and Functional Leads to maintain TMF in an inspection-ready state
• Ensure TMF Risks are identified, documented and mitigated
• Monitor and report on TMF Health and Metrics and escalate non-compliances
• Identify trends, risks, and overall status of the TMF and suggest mitigation strategies
• Support Audits and Inspections and participate in interviews
• Manage close-out activities of assigned studies

Required qualifications

• Bachelor’s degree (or its international equivalent)
• A minimum of 3 years of related experience or equivalent combination of education, professional training and experience
• Professional working proficiency in English
• Fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
• Experience with eTMF systems and vendors
• Working knowledge of FDA & ICH/GCP regulations and guidelines

About the company

Precision Medicine Group is an Equal Opportunity Employer.