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ICON plc

TMF Lead

Posted 4 days ago
5-10 years experience
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AI Summary

The TMF Lead oversees trial master file management workstreams to ensure compliance with regulatory standards and internal policies. They collaborate with cross-functional teams to maintain accurate documentation and conduct regular quality checks and audits.

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%)

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

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