TMF Group Lead

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