Key Responsibilities
- Lead development and 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.
- Partner with Clinical Operations, Data Management, Biostatistics, and other stakeholders to review data flows, critical data pathways, and data review requirements.
- Provide strategic 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.
- 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.
- Support program-level and organizational RBQM governance and oversight activities.
- Serve as the primary escalation point for RBQM-related risks and quality issues.
- Contribute to continuous improvement initiatives to enhance RBQM maturity and effectiveness across the organization.
Qualifications & Experience:
- Over 10+ years of 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:
- 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 in implementing and operationalizing RBQM frameworks.
Leadership & Strategic Capability:
- 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.
ICON offers a range of benefits designed to enhance your well-being and work-life balance, including various annual leave entitlements, health insurance offerings, retirement planning options, and more. ICON is committed to providing an inclusive and accessible work environment free of discrimination and harassment. If you require a reasonable accommodation during the application process, please let us know. Apply now to explore opportunities at ICON, where inclusion and belonging are fundamental to our culture and values. As an RBQM Manager at ICON plc, you will play a crucial role in leading the implementation and execution of proactive, risk-focused quality oversight across global clinical studies. Your responsibilities will include:
Key Responsibilities
- Lead development and 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.
- Partner with Clinical Operations, Data Management, Biostatistics, and other stakeholders to review data flows, critical data pathways, and data review requirements.
- Provide strategic input into Risk-Based Monitoring (RBM) strategies, including targeted SDV/SDR approaches and reduced verification models.
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