TMF Specialist

Home Based - MX

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a TMF Specialist III to join our diverse and dynamic team. As a TMF Specialist III at ICON, you will play a crucial role in participating client services contracts and internal business needs by managing Trial Master File (TMF) documentation. You will ensure compliance with client requirements and ICON procedures while contributing to the efficiency and effectiveness of our TMF processes.

What You Will Be Doing:

• 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:

• A minimum of 3 years of experience in clinical research or document management within the pharmaceutical, biotechNlogy, or CRO industry

• Proficiency in Trial Master File (TMF) management and familiarity with regulatory requirements (ICH-GCP, FDA, EMA, etc.)

• 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

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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

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.