ICON plc
Lead Business Operations Specialist
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RBQM Lead
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
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.
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.
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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.
What ICON Can Offer You
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
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In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our Benefits Examples Include
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
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