Study Start Up Associate I

IVDR Study Start-Up Associate - UK

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.

At ICON, you will play a key role in the successful start-up and activation of In Vitro Diagnostics (IVD) clinical studies, helping to bring innovative diagnostic solutions and healthcare advancements to patients worldwide. As an IVD Study Start-Up Associate, you will partner with cross-functional teams, investigative sites, and regulatory stakeholders to ensure studies are initiated efficiently and in compliance with applicable regulations and timelines.

What You Will Do

As part of our Study Start-Up team, you will be responsible for delivering high-quality site activation and regulatory submission activities across a range of IVD clinical studies.

Key responsibilities include:

• Preparing, compiling, and submitting regulatory and ethics documentation, including clinical trial applications and ethics committee submissions.
• Coordinating with internal teams, sponsors, regulatory authorities, and investigative sites to secure required approvals and authorisations for study initiation.
• Maintaining accurate and inspection-ready records of regulatory submissions, approvals, and essential study documents.
• Supporting study teams in the development, review, and management of key study documentation, including protocols, informed consent forms, and investigator brochures.
• Participating in study start-up meetings, providing guidance on regulatory requirements, timelines, and activation strategies.
• Tracking study start-up milestones and proactively identifying and resolving issues that may impact activation timelines.
• Ensuring all activities are conducted in accordance with applicable regulations, ICH-GCP guidelines, and company SOPs.

What You Will Bring

To be successful in this role, you will have experience supporting clinical study submissions and site activation activities, with a strong understanding of regulatory processes and study start-up requirements.

Required qualifications and experience:

• 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%.

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