Lead Business Operations Specialist
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Job Description
RBQM Lead overseeing risk-based quality management for ICON’s global clinical research studies. Driving risk assessments, monitoring strategies, governance, and inspection readiness across clinical trials.
Responsibilities:
- 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
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