Study Start Up Associate I

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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

🎯 Requirements

• 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%

🏖️ Benefits

• 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