Lead Business Operational Specialist / RBQM Lead

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

We are seeking an experienced and forward-thinking Risk-Based Quality Management (RBQM) Lead to support the implementation and execution of proactive, risk-focused quality oversight across clinical studies.

As an RBQM Lead, you will serve as a subject matter expert and change leader, ensuring risk-based principles are embedded throughout the clinical trial lifecycle,from study design through execution and governance. This global role will drive the implementation of study level RBQM strategies, standards, and initiatives to strengthen quality oversight and inspection readiness.

Key Responsibilities

RBQM Planning & Risk Assessment

• 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 (CtQ) factors, critical data, and critical processes.
• Coordinate and oversee initial and ongoing risk assessments, ensuring timely identification of risks and implementation of mitigation strategies.
• Ensure risk assessments, risk controls, and mitigation plans are complete, actionable, and aligned with regulatory expectations.

Cross-Functional Collaboration & Oversight

• 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 (RBM) strategies, including targeted SDV/SDR approaches and reduced verification models.
• Perform quality gate reviews of functional plans to confirm integration of risk mitigation and monitoring strategies.

Ongoing Risk Management & Oversight

• Lead and facilitate Risk Review Meetings (RRMs) and ensure comprehensive documentation of risk evaluations and decisions.
• Oversee ongoing risk surveillance to 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.

Governance & Quality

• Support program-level and organizational RBQM governance and oversight activities.
• Contribute to continuous improvement initiatives to enhance RBQM maturity and effectiveness across the organization.

Qualifications & Experience

• Comprehensive clinical research experience, collaborating with global teams within a matrixed organizational environment.
• Significant experience in clinical research within one or more of the following areas: Risk-Based Quality Management (RBQM), Clinical Operations, Central Monitoring, Clinical Risk Management, Clinical Data Science.

Technical Expertise & Capability

• 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.

Mindset & Behaviors

• 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.

Rewards & 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.