Clinical Trial Documentation 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.
We are currently seeking a Clinical Trial Documentation Specialist (TMF Specialist I) to join our diverse and dynamic team. As the Specialist at ICON, you will play a vital role in becoming familiar with Trial Master File (TMF) documentation and document management activities. You will contribute to client services contracts and internal ICON business needs, ensuring compliance with client requirements and ICON procedures.
What You Will Be Doing:
Supporting the maintenance, organization, and quality of Trial Master File (TMF) documentation
Contributing to client service deliverables and internal ICON initiatives related to TMF management
Ensuring adherence to client-specific requirements and internal ICON procedures
Collaborating with cross-functional teams to ensure timely, accurate, and compliant document filing
Applying knowledge of ICH-GCP guidelines in daily operational tasks
Assisting in clinical research activities, particularly in roles such as Clinical Trial Associate, Documentation Specialist, or TMF Specialist
Managing workload effectively by prioritizing tasks and meeting deadlines
Communicating clearly and professionally with internal teams and external stakeholders
Adapting to a dynamic work environment and maintaining performance under time pressure
Identifying and resolving issues using analytical and problem-solving skills
Responding to client and team needs with a proactive, customer-focused approach
Utilizing Microsoft Office tools (Outlook, Excel, Word, Teams) to support documentation and communication tasks
Your Profile:
Bachelor’s degree or higher in life sciences, healthcare, or pharmaceutical-related fields preferred
Clinical research experience preferred (e.g. as Clinical Trial Associate, Documentation Specialist, TMF Specialist)
Familiarity with electronic Trial Master File (eTMF) systems; experience with Veeva Vault is strongly preferred
Understanding of TMF documentation and document management processes preferred
Strong organizational and time management skills
Excellent communication and interpersonal abilities
Flexibility and adaptability in a fast-paced, changing environment
Analytical thinking and effective problem-solving skills
Customer-oriented mindset with a sense of urgency
Proficiency in Microsoft Office suite (Outlook, Excel, Word, Teams)
Advanced verbal and written English language 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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
