Clinical Trial Manager – Regulatory Submissions

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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 preparation and submission of essential documents for regulatory approvals and site activation • Collaborate with project management, clinical operations, and regulatory affairs to streamline study start-up processes • Oversee the identification and selection of clinical sites, ensuring they meet project criteria and compliance standards • Provide guidance and support to study teams and sites during the start-up phase • Stay current with industry regulations and trends to enhance start-up strategies and best practices • Coordinate site start-up and activation delivery, resolve issues, and develop team capability

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Extensive experience in study start-up activities within the clinical research industry, with a strong understanding of regulatory requirements • Proven ability to manage multiple projects and prioritize tasks effectively in a fast-paced environment • Excellent organizational skills and attention to detail, with a commitment to delivering high-quality results • Strong communication and interpersonal skills, enabling effective collaboration with diverse teams and external stakeholders • A commitment to maintaining high standards of quality and compliance in all study start-up activities • Willingness to travel as required (approximately 15%) • Legal right to work in the country where the role is based

🏖️ 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