ICON-FSP-CTA (SSU)- Homebased
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 Administrator to join our diverse and dynamic team. As a Clinical Trial Administrator at ICON, you will play a pivotal role in assisting with the design and analysis of clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies.
What You Will Be Doing
- Recognize, exemplify, and adhere to ICON's core values, centered on People, Clients, and Performance.
- Contribute to a culture of continuous improvement by supporting efficient, high-quality processes that meet client and study needs.
- Provide administrative and operational support to the Study Start-Up team, with a primary focus on regulatory document management and submission dossier preparation.
- Support Study Start-Up Leads and team members in coordinating study start-up activities and documentation.
- Compile, organize, and maintain complete and high-quality regulatory submission dossiers in accordance with ICH-GCP, local regulations, and sponsor requirements.
- Assist in the collection, review, and verification of essential documents to ensure submission packages are accurate, complete, and audit-ready.
- Prepare and format submission documents and dossiers for submission to Ethics Committees (EC), Health Authorities (HA), and other regulatory bodies.
- Support the development and execution of submission strategies by providing operational input, tracking requirements, and ensuring alignment with study timelines and local regulations.
- Coordinate, dispatch, and track submissions, ensuring timely follow-up and proper documentation of submission status.
- Support translation and localization of submission documents, including coordination with vendors where required.
- Maintain accurate and up-to-date records in CTMS and/or other tracking systems to reflect submission progress and key milestones.
- Organize and maintain electronic filing systems, ensuring proper version control and document traceability.
- Support Trial Master File (TMF) readiness by ensuring documents are complete, accurate, and filed in a timely manner
- Support meeting logistics, including scheduling, documentation, and meeting minutes.
- Assist in preparation of study-related reports and presentation materials, as needed.
- assist in managing importing and exporting study related materials equipment, IP, kit...ect
- Develop working knowledge of ICH-GCP, applicable regulatory requirements, and internal SOPs.
- Support submission-related activities (e.g., notifications, amendments) under supervision.
- May require limited domestic and/or international travel (5%), as needed.
- Other duties as assigned
Your profile
- Bachelor's degree in a scientific or healthcare-related field.
- Prior experience in IRB initial submission
- Excellent organizational and communication skills.
- Ability to work collaboratively in a fast-paced environment with attention to detail.
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
