ICON plc
Lead Business Operations Specialist
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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.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients, and suppliers.
Job title – Lead Business Operations Specialist
Job role - RBQM Lead
About the Role
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.
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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.
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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.
Employment
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance-related incentives
- Health and wellbeing programs including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programs and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply.
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