Risk Surveillance Lead

Job not on LinkedIn

🔥 12 hours ago

🌐 United Kingdom, Spain, +1 more countries – Remote

🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇮🇪 Ireland – Remote

⏰ Full Time

🟠 Senior

🎲 Risk

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Facilitate trial protocol risk assessment across multiple cross-functional domains associated to critical-to-quality data and processes, including definition of quality tolerance limits, evaluation of risks, and ensuring mitigation strategies/plans are defined • Draft, maintain, and archive study-specific documentation of risk management activities • Partner with the RBQM system configuration team to ensure risk indicators, quality tolerance limits, and analytics/visualizations are programmed and functioning per operational requirements • Conduct periodic central surveillance of aggregate data at study and program level to identify emerging risks and/or issues • Facilitate risk review meetings and discussions with study/program team members to communicate findings and support root cause identification and mitigation strategies • Support and participate in internal and external audits and inspections • Collaborate with training departments to support training initiatives and adoption of the RBQM approach • Drive adoption of RBQM practice at trial level and oversee implementation and continuous improvement • Maintain overall accountability for surveillance of quality risks across assigned trials and program within a matrix environment

🎯 Requirements

• Must be based in the UK, Spain or Ireland (remote) • 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 • Employment with ICON is contingent upon having the 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