Study Start-up Associate II

🕒 June 12

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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

• Lead the initiation of clinical trials, ensuring compliance with regulatory requirements • Contribute to site start-up and activation activities • Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications • Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation • Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence • Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities • Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency

🎯 Requirements

• Bachelor's degree in life sciences or a related field • 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor • Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements • Experience in reviewing site ICFs and interactions with IRBs/ECs • Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously • Advanced English level • 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