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.
🔥 21 hours ago
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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.
• Shape and execute Study Start-Up strategies across global, multi-country studies • Lead the development and delivery of comprehensive Study Start-Up Plans covering regulatory, ethics, and contract execution • Drive end-to-end start-up activities from site identification through IP release • Provide strategic input at Bid Defence and Kick-Off meetings • Oversee regulatory and ethics submissions across regions • Manage site contract and budget negotiations with legal, finance, and sponsors • Identify risks, dependencies, and bottlenecks and implement mitigation and escalation strategies • Partner with Project Managers and cross-functional stakeholders • Ensure accuracy, quality, and inspection readiness of study documentation, including CTMS and eTMF activities • Lead and coordinate Study Start-Up team members • Drive process consistency and continuous improvement across regions • Maintain oversight of study metrics, budgets, and scope of work • Provide reporting and updates to sponsors and internal leadership
• Bachelor's degree in Life Sciences or a related field • Recent Study Start-Up (SSU) experience with end-to-end site activation responsibility • Experience supporting global and multi-country clinical trials • Strong knowledge of CA/EC submissions, CTA processes, and regulatory requirements • Experience managing site contracts, budgets, and start-up timelines • Working knowledge of CTMS, eTMF, and other clinical systems • Solid understanding of ICH-GCP and applicable regulations • Strong stakeholder management, communication, and collaboration skills • Organized, proactive, and solution-oriented approach • Legal right to work in the country where the role is based
• 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
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