IVDR Study Start-Up Associate - UK

Job title: IVDR Study Start-Up Associate - UK

About the Role Join ICON as an IVDR Study Start-Up Associate in the UK. You will play a key role in the successful start-up and activation of In Vitro Diagnostics (IVD) clinical studies, partnering 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'll Do

• 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 We're Looking For

• 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%.

Nice to Have

• Experience in In Vitro Diagnostics (IVD) studies is highly desirable.

Compensation & Benefits

• Our offer includes a competitive salary and a range of benefits designed to support well-being and work-life balance. Benefits may include: annual leave entitlements, health insurance options, retirement planning, Global Employee Assistance Programme LifeWorks, life assurance, flexible country-specific benefits, and more. ICON is committed to inclusion and belonging, and to providing an accessible environment for all candidates. For more details, visit our careers site.