TMF Group Lead

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

Homebased role

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Group Lead - Trial Master File (TMF) Operations at ICON, you will provide oversight and leadership for TMF processes, ensuring compliance and quality in document management across clinical trials.

What You Will Do:

You will manage trial master file management activities across your area, ensuring your team delivers to the highest standards.

Key responsibilities include:

• Leading and managing the TMF Operations team to ensure timely and accurate handling of clinical trial documentation.
• Overseeing TMF processes and workflows to ensure compliance with regulatory requirements and industry standards.
• Collaborating with cross-functional teams to support the maintenance, inspection, and archival of TMF documents.
• Providing training and guidance to team members, promoting best practices in TMF management.
• Monitoring performance metrics and implementing improvements to enhance TMF quality and efficiency.

Your Profile:

You will have a strong background in trial master file management, with proven management experience and a commitment to quality delivery.

Required qualifications and experience:

• Bachelor's degree in life sciences, information management, or a related field, or equivalent experience.
• Extensive experience in TMF operations within clinical research or the pharmaceutical industry.
• Strong understanding of regulatory requirements and best practices related to TMF management.
• Proven leadership skills with the ability to manage and motivate a team effectively.
• Excellent communication and organizational skills, with attention to detail and a commitment to quality.
• Willingness to travel as required (approximately 5%)

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)