ICON seeks a Trial Master File Lead to oversee TMF management processes for clinical trials, ensuring regulatory compliance and quality standards. The remote Mexico-based role involves managing documentation workstreams, conducting audits, and leading cross-functional teams to maintain best practices in clinical research.
Responsibilities
Lead setup, maintenance, and oversight of TMF in compliance with regulatory standards and policies
Oversee TMF management workstreams and ensure deliverables meet quality and timeline expectations
Conduct regular TMF quality checks and audits to identify and resolve discrepancies
Provide training and support to team members on TMF processes and best practices




Develop and implement continuous improvement strategies for TMF management and documentation
Requirements
Bachelor's degree in life sciences, documentation management, or related discipline
Proven TMF management or clinical trial document management experience in healthcare/clinical research
Strong understanding of regulatory requirements and TMF/clinical documentation industry standards
Excellent organizational skills with meticulous attention to detail and accuracy
Strong communication and interpersonal skills for cross-functional collaboration
Willingness to travel approximately 5% as required

📌 Tmf Lead (Xico)
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📍 Xico