ICON

Sr. eTMF Specialist

US, Raleigh, NC Full time
Sr. eTMF Specialist

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

As a Trial Master File (TMF) Specialist II at ICON, you will ensure the accuracy and completeness of the Trial Master File (TMF) throughout the clinical trial process.

What You Will Do:

You will contribute to trial master file management activities, taking responsibility for your deliverables and working collaboratively.

Key responsibilities include:

  • Managing the quality and integrity of the TMF by ensuring timely and accurate document uploads and metadata management.
  • Collaborating with cross-functional teams to identify and resolve discrepancies in TMF documentation.
  • Conducting regular audits of the TMF to ensure compliance with regulatory requirements and internal procedures.
  • Providing training and support to team members on TMF best practices and document management systems.
  • Generating reports and metrics to track TMF status and provide insights for continuous improvement.

Your Profile:

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

Required qualifications and experience:

  • Bachelor's degree in life sciences, healthcare, or a related field.
  • 2+ years of experience in clinical trial operations or document management, with a focus on Trial Master File processes.
  • Strong attention to detail and organizational skills, with a commitment to maintaining high-quality standards.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse teams.
  • Proficiency in electronic document management systems and an understanding of regulatory requirements related to TMF.
  • 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, 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 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.

Are you a current ICON Employee? Please click here to apply