TMF Quality Review Jr. Associate

ICON Strategic Solutions; México; Remote; MXN 500,000 - 900,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance options

Retirement planning

Job summary

ICON Strategic Solutions is hiring for a Home Based TMF Manager in Mexico. You will take responsibility for TMF documentation, ensuring completeness and regulatory compliance across trial lifecycles.

You will partner with cross-functional teams to gather and maintain essential documents for regulatory submissions. Qualified candidates bring 3+ years in clinical research or document management, a life sciences degree, and strong attention to detail with excellent communication skills.

Qualifications

• Minimum 3 years of experience in clinical research or document management.
• Bachelor's degree in life sciences or related discipline is required.
• Strong attention to detail and ability to manage multiple tasks concurrently.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Manage Trial Master File (TMF) documentation in line with client requirements and ICON procedures.
• Ensure completeness, accuracy, and timeliness of TMF documents throughout trial lifecycles.
• Collaborate with cross-functional teams to collect, review, and maintain essential 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

Attention to detail

Organizational skills

Communication skills

Cross-functional collaboration

Travel willingness

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.

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

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.