Trial Master File Lead — Remote

ICON Clinical Research; México; Remote; MXN 1,000,000 - 1,400,000; Full time

Job summary

ICON is seeking a Group Lead - Trial Master File (TMF) Operations to provide oversight across TMF processes in a homebased role.

You will manage TMF operations for clinical trials, ensure regulatory compliance, lead a team, and collaborate with cross-functional groups to maintain high-quality TMF documentation while traveling up to 5% as required.

The role emphasizes quality, training, performance monitoring, and process improvements in a global context.

Qualifications

• Bachelor's degree in life sciences, information management, or related field or equivalent experience.
• Extensive TMF operations experience in clinical research or pharmaceutical industry.
• Strong understanding of regulatory TMF requirements and best practices.
• Proven leadership with ability to motivate and manage a team.
• Excellent communication and organizational skills with attention to detail.

Responsibilities

• Lead the TMF Operations team to ensure timely and accurate handling of clinical trial documentation.
• Oversee TMF processes and workflows to ensure regulatory compliance and industry standards.
• Collaborate with cross-functional teams to support maintenance, inspection, and archival of TMF documents.
• Provide training and guidance to team members, promoting best practices in TMF management.
• Monitor performance metrics and implement improvements to enhance TMF quality and efficiency.

Skills

Leadership

Team management

Regulatory knowledge

TMF operations experience

Communication

Education

Bachelor's degree in life sciences or related field

Job description

ICON is seeking a Group Lead - Trial Master File (TMF) Operations to provide oversight across TMF processes in a homebased role.

You will manage TMF operations for clinical trials, ensure regulatory compliance, lead a team, and collaborate with cross-functional groups to maintain high-quality TMF documentation while traveling up to 5% as required.

The role emphasizes quality, training, performance monitoring, and process improvements in a global context.