TMF Lead at ICON plc

Ciudad de México, , Mexico -

Full Time

Start Date

Immediate

Expiry Date

28 Aug, 26

Salary

0.0

Posted On

30 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

TMF Management, Regulatory Compliance, Clinical Trial Documentation, Quality Auditing, Cross-functional Collaboration, Team Leadership, Process Improvement, Attention To Detail, Interpersonal Communication, Organizational Skills

Industry

Biotechnology Research

Description

TMF Lead - Hybrid - Mexico City 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 work office based 3 times a week - Benito Juarez / Mexico City #LI-Remote #LI-AR1 Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Responsibilities

Oversee Trial Master File (TMF) management processes to ensure compliance with regulatory requirements and internal policies. Lead the setup, maintenance, and quality auditing of documentation while providing training and support to team members.