TMF Lead II (LATAM)
Core
Lead the maintenance, quality review, and archival of Trial Master Files (TMF) for clinical studies in the LATAM region, ensuring compliance with GCP and internal SOPs.
Role type
Senior Clinical Trial Master File (TMF) Lead
Builds
Inspection-ready TMFs for Precision Medicine Group studies
Domain
Clinical Research / Regulatory Compliance
Required skills
GCP/ICH/FDA regulations, eTMF systems, TMF Plan/Document Index management, audit support, risk identification, close-out activities, training coordination
Preferred skills
Microsoft Office proficiency, stakeholder communication, trend analysis
Technologies
eTMF systems, Microsoft Office (Outlook, Word, Excel, PowerPoint)
Responsibilities
Ensure timely and high-quality TMF document review, processing, periodic quality review, and archival; Create and execute study TMF Plans and Document Indexes; Monitor TMF health metrics and escalate risks; Support audits and inspections; Manage study close-out activities including eTMF export and transfer; Coordinate training for project teams.
Seniority
Mid-Senior, hands-on IC