ICON seeks a Group Lead for Trial Master File Operations to oversee TMF processes and lead a team managing clinical trial documentation. The role ensures regulatory compliance and document quality across trials, based remotely in Mexico City.
Responsibilities
Lead and manage the TMF Operations team for timely, accurate clinical trial documentation handling
Oversee TMF processes and workflows to maintain regulatory compliance and industry standards
Collaborate cross-functionally on maintenance, inspection, and archival of TMF documents
Provide team training and guidance to promote TMF management best practices
Monitor performance metrics and implement improvements to enhance quality and efficiency
Requirements
Bachelor's degree in life sciences, information management, or equivalent experience
Extensive TMF operations experience within clinical research or pharmaceutical industry
Strong knowledge of regulatory requirements and TMF management best practices
Proven leadership and team management skills
Excellent communication, organizational, and attention-to-detail abilities
Willingness to travel approximately 5% as required

📌 Tmf Group Lead (Xico)
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📍 Xico