Study Start Up Associate

Overview

IVDR Study Start-Up Associate - UK

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are committed to an inclusive environment that drives innovation and excellence. We invite you to help shape the future of clinical development by joining our team.

At ICON, you will play a key role in the start-up and activation of In Vitro Diagnostics (IVD) clinical studies, collaborating with cross-functional teams, investigative sites, and regulatory stakeholders to ensure studies are initiated efficiently and in compliance with applicable regulations and timelines.

• Deliver high-quality site activation and regulatory submission activities across a range of IVD clinical studies.
• Prepare, compile, and submit regulatory and ethics documentation, including clinical trial applications and ethics committee submissions.
• Coordinate with internal teams, sponsors, regulatory authorities, and investigative sites to secure required approvals and authorisations for study initiation.
• Maintain accurate and inspection-ready records of regulatory submissions, approvals, and essential study documents.
• Support study teams in developing, reviewing, and managing key study documentation, including protocols, informed consent forms, and investigator brochures.
• Participate in study start-up meetings, providing guidance on regulatory requirements, timelines, and activation strategies.
• Track study start-up milestones and proactively identify and resolve issues that may impact activation timelines.
• Ensure all activities are conducted in accordance with applicable regulations, ICH-GCP guidelines, and company SOPs.

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Previous experience in clinical research, study start-up, regulatory affairs, or site activation within a CRO, sponsor, or healthcare environment.
• Hands-on experience preparing and coordinating UK clinical study submissions.
• Knowledge of applicable regulatory requirements and clinical research processes.
• Strong organisational skills with the ability to manage multiple priorities and timelines.
• Excellent communication and stakeholder management skills.
• Experience in In Vitro Diagnostics (IVD) studies is highly desirable.
• Willingness to travel within the UK occasionally, approximately 5%.

Our success depends on the quality of our people. We are committed to building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance for you and your family.

• Annual leave entitlements
• Health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings
• Global Employee Assistance Programme, Life Works, offering 24-hour access to a global network of professionals for well-being support
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

For more information about ICON benefits, visit the careers site.

At ICON, inclusion and belonging are fundamental to our culture and values. We are committed to an inclusive and accessible environment for all candidates. 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 you need a reasonable accommodation for any part of the application process or to perform essential functions of a position, please let us know.

Interested in the role but unsure if you meet all requirements? We encourage you to apply regardless—there’s every chance you’re exactly what we’re looking for at ICON, whether for this role or others.

Are you a current ICON employee? Please apply through the internal process if applicable.