Study Start Up Associate

IVDR Study Start‑Up Associate - UK

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values‑driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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.

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.

• 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.

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%.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance‑related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Benefits may vary depending on role and location.

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.