TMF Quality Review Jr. Associate

ICON; Ciudad de México; Remote; MXN 1,128,000 - 1,693,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning options

Global Employee Assistance Programme (

Life assurance

Job summary

ICON Strategic Solutions in Mexico is seeking a TMF Specialist III to manage Trial Master File documentation for clinical trials. This home-based role supports sponsor contracts and cross-functional teams to ensure compliance and timely submissions.

You will oversee TMF documentation lifecycle, conduct quality checks, and provide guidance to stakeholders while collaborating with global teams. Travel about 5% may be required.

Qualifications

• At least 3 years in clinical research or document management.
• Bachelor's degree in life sciences or related field.
• Strong attention to detail and ability to multitask.
• Excellent written and verbal communication for cross-functional teams.
• Willingness to travel ~5%.

Responsibilities

• Manage TMF documentation per client requirements and ICON procedures.
• Ensure completeness, accuracy, and timeliness of TMF documentation throughout trial lifecycles.
• Collaborate with cross-functional teams to collect, review, and maintain documents for regulatory submissions.
• Conduct quality checks and audits of TMF documents to ensure regulatory compliance.
• Provide guidance to internal and external stakeholders on TMF-related matters.

Skills

TMF management

Regulatory documentation

Cross-functional communication

Attention to detail

Organizational skills

Education

Bachelor's degree in life sciences

Bachelor's degree in a related field

Job description

Home Based - Mexico - TMF

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Trial Master File (TMF) Specialist III at ICON, you will participate in client services contracts and internal business needs by managing Trial Master File (TMF) documentation.

What You Will Do:

You will take responsibility for trial master file management deliverables, applying your skills to ensure quality and efficiency.
Key responsibilities include:

• Manage Trial Master File (TMF) documentation in accordance with client requirements and ICON procedures
• Ensure the completeness, accuracy, and timeliness of TMF documentation throughout the lifecycle of clinical trials
• Partnership with cross-functional teams to collect, review, and maintain essential documents for regulatory submissions
• Conduct quality checks and audits of TMF documents to ensure compliance with regulatory standards and sponsor requirements
• Provide efforts and guidance to internal and external stakeholders on TMF-related matters

Your Profile:

You will bring relevant trial master file management experience, along with the following qualifications and skills.
Required qualifications and experience:

• A minimum of 3 years of experience in clinical research or document management within the pharmaceutical, biotechnology, or CRO industry
• Bachelor's degree in life sciences, documentation management, or a related discipline
• Strong attention to detail and organizational skills, with the ability to manage multiple tasks simultaneously
• Excellent communication skills, with the ability to partnership effectively with cross-functional teams
• Bachelor's degree in a relevant field preferred
• 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 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