TMF Lead

ICON Clinical Research; México; Remote; MXN 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Various annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme

Life assurance

Job summary

ICON Clinical Research is looking for a TMF Lead to oversee trial master file management remotely in Mexico, ensuring compliance with regulatory standards and internal policies. You will collaborate with cross-functional teams, maintain TMF deliverables, and drive continuous improvement.

The role requires solid TMF/documentation experience, a life sciences degree, and willingness to travel about 5%. ICON emphasizes inclusion and a comprehensive benefits program.

Qualifications

• Bachelor's degree in life sciences, documentation management, or related field.
• Proven TMF management or clinical trial document management experience.
• Strong knowledge of regulatory standards for TMF and documentation.

Responsibilities

• Lead setup, maintenance, and oversight of the TMF in compliance with regulatory standards and internal policies.
• Collaborate with cross-functional teams to ensure timely, accurate TMF documentation.
• Perform regular TMF quality checks and audits to identify and resolve discrepancies.
• Provide training and support on TMF processes and best practices.
• Develop and implement continuous improvements in TMF management and documentation.

Skills

TMF management

Leadership

Cross-functional collaboration

Documentation quality

Education

Bachelor's degree in life sciences

Job description

TMF Lead - Remote - Mexico

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 Trial Master File (TMF) Lead at ICON, you will be responsible for overseeing the Trial Master File (TMF) management processes, ensuring compliance with regulatory requirements and best practices in clinical trials.

What You Will Do:

You will oversee trial master file management workstreams, ensuring deliverables meet quality and timeline expectations.

Key responsibilities include:

• Leading the setup, maintenance, and oversight of the TMF in compliance with regulatory standards and internal policies.
• Collaborating with cross-functional teams to ensure timely and accurate documentation within the TMF.
• Conducting regular TMF quality checks and audits to identify and resolve discrepancies or issues.
• Providing training and support to team members on TMF processes and best practices.
• Establishing and implementing strategies for continuous improvement in TMF management and documentation practices.

Your Profile:

You will have solid trial master file management experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• Bachelor's degree in life sciences, documentation management, or a related discipline
• Proven experience in TMF management or clinical trial document management, preferably within the healthcare or clinical research industry.
• Strong understanding of regulatory requirements and industry standards related to TMF and clinical documentation.
• Excellent organizational skills and attention to detail, ensuring compliance and accuracy in TMF management.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
• A commitment to promoting equity and inclusion in all aspects of TMF management.
• 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)

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.