Risk Based Site Management Lead

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🕒 May 11

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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

• Provide end-to-end risk oversight for assigned clinical studies • Ensure risks to patient safety, data quality, and trial integrity are proactively identified, discussed, and managed throughout the study lifecycle. • Work in close partnership with the Clinical Research Manager (CRM) and broader study team • Facilitate risk-focused discussions and drive clear, practical mitigation strategies • Lead and maintain study-level risk assessments for assigned sponsor studies • Facilitate and chair cross-functional risk review meetings, ensuring focus on critical data and processes • Drive proactive identification, discussion, and documentation of study risks • Review centralized monitoring outputs, KRIs, KPIs, and trends to detect emerging or systemic risks • Support issue escalation, root cause analysis, and risk mitigation planning • Ensure risk-based activities align with set principles and sponsor expectations • Contribute to inspection readiness through clear documentation and defensible oversight decisions.

🎯 Requirements

• Experience in clinical trial operations, study management, monitoring, or centralized oversight • Solid understanding of risk-based monitoring and study management principles • Knowledge of ICH-GCP, regulatory standards, and quality frameworks • Strong facilitation skills with confidence leading cross-functional discussions • Analytical mindset with the ability to interpret data, trends and signals • Excellent communication and stakeholder management skills • Ability to operate independently while collaborating effectively with sponsor and ICON teams.

🏖️ Benefits

• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs. • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.