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.