About this role
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 Senior TMF Specialist to join our diverse and dynamic team. As a Senior TMF Specialist at ICON, you will play a pivotal role in managing the Trial Master File (TMF) for clinical trials, ensuring compliance with regulatory requirements and contributing to the advancement of inNvative treatments and therapies.
What you will be doing- Managing and maintaining the Trial Master File (TMF) for assigned clinical trials.
- Ensuring the completeness, accuracy, and quality of TMF documents throughout the trial lifecycle.
- Collaborating with study teams to ensure timely collection, processing, and filing of essential documents.
- Conducting TMF audits and inspections to ensure compliance with regulatory standards and sponsor requirements.
- Providing support and guidance on TMF-related matters to internal stakeholders.
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 3 years of experience in clinical research or TMF management.
- Strong understanding of TMF regulations, guidelines, and best practices.
- Proficiency in electronic document management systems and TMF software.
- Excellent organizational, communication, and attention to detail skills.
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
Other facts
About ICON plc
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
What you'll do
- The Senior TMF Specialist will manage and maintain the Trial Master File (TMF) for clinical trials, ensuring compliance with regulatory requirements. This role involves collaborating with study teams and conducting TMF audits to ensure document accuracy and quality.
Ready to join ICON plc?
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