Risk Surveillance Lead

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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

• Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evalua-tion of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined • Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities • Partners with the RBQM system configuration team to ensure risk indicators, quality tol-erance limits and other analytics/visualizations are programmed and functioning per op-erational requirements in the RBQM system • Conduct of periodic central surveillance of the aggregate data at the study and program level, leveraging available analytics/visualizations in the RBQM system, to identify emerg-ing risks and/or issues • Facilitate risk review meetings and discussions with study / program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies • Supports and participates in internal and external audits and inspection • Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.

🎯 Requirements

• Bachelor’s Degree in a health-related, life science area, or equivalent combination of education, training, and work experience • Minimum of 6 years of experience in the pharmaceutical or CRO industry • Minimum of 2 years of experience in Risk Based Quality Management • Robust understanding of the drug development process and clinical trial execution • Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP) • Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions • Knowledge of RBQM IT systems or other data analytic systems • Demonstrated ability to analyze data, identify patterns and make recommendations for improvement • Demonstrated ability to effectively lead cross functional team meetings • Experience forming cross-functional collaborations; strong interpersonal skills

🏖️ 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