Lead Business Operations Specialist

🔥 0 minutes ago

🌐 United Kingdom, Portugal, +2 more countries – Remote

🇬🇧 United Kingdom – Remote 🇵🇹 Portugal – Remote 🇪🇸 Spain – Remote 🇧🇬 Bulgaria – Remote

⏰ Full Time

🟠 Senior

⚙️ Business Operations

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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 execution of Quality and Risk Management planning in alignment with study and program objectives • Facilitate cross-functional workshops to identify and document Critical-to-Quality factors, critical data, and critical processes • Coordinate and oversee initial and ongoing risk assessments • Ensure risk assessments, risk controls, and mitigation plans are complete, actionable, and aligned with regulatory expectations • Partner with Clinical Operations, Data Management, Biostatistics, and other stakeholders to review data flows, critical data pathways, and data review requirements • Provide input into Risk-Based Monitoring strategies, including targeted SDV/SDR approaches and reduced verification models • Perform quality gate reviews of functional plans • Lead and facilitate Risk Review Meetings and document risk evaluations and decisions • Oversee ongoing risk surveillance and ensure monitoring strategies remain effective and aligned with study timelines and budgets • Ensure risk review outputs provide meaningful insights, trend analysis, and actionable recommendations • Update risk assessments based on protocol amendments, emerging signals, or changes to critical data and processes • Support program-level and organizational RBQM governance and oversight activities • Contribute to continuous improvement initiatives to enhance RBQM maturity and effectiveness across the organization • Lead implementation and execution of proactive, risk-focused quality oversight across clinical studies • Drive implementation of study-level RBQM strategies, standards, and initiatives to strengthen quality oversight and inspection readiness

🎯 Requirements

• Comprehensive clinical research experience, collaborating with global teams within a matrixed organizational environment • Significant experience in clinical research in Risk-Based Quality Management (RBQM), Clinical Operations, Central Monitoring, Clinical Risk Management, or Clinical Data Science • Strong knowledge of ICH E6 (R2/R3), ICH E8, and their application to RBQM • Deep understanding of clinical trial processes, data flows, and risk-based monitoring strategies • Demonstrated expertise implementing RBQM methodologies for multiple projects • Proven ability to lead cross-functional initiatives and influence stakeholders globally • Strong strategic thinking with the ability to translate regulatory expectations into operational practice • Excellent communication, stakeholder engagement, and facilitation skills • Proactive and solutions-oriented with a strong focus on quality and continuous improvement • Ability to operate effectively in complex, global environments • Strong critical thinking and risk anticipation capabilities • Passion for mentoring teams and strengthening RBQM capabilities across the organization • Commitment to fostering an inclusive and collaborative culture • 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