Study Start-up Associate II

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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

• Contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively • Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications • Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation • Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence • Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities • Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency

🎯 Requirements

• Bachelor's degree in life sciences or a related field • Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities • Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements • Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams • Willingness to travel as required (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