Associate Director, Risk Based Quality Management, Oncology
Job Description:
• Provide study-level leadership for risk-based quality management across Phase 1–4 oncology clinical trials
• Drive data-driven quality oversight, ensuring clinical trial risks are proactively identified, monitored, and mitigated
• Facilitate understanding of the SMPA RBQM Strategy within Clinical Project Teams by providing targeted training sessions
• Lead and facilitate cross-functional risk assessment meetings
• Maintain comprehensive and traceable documentation of all risk assessment activities
• Own the development, maintenance, and ongoing updates of Risk Assessment Categorization Tools (RACT) and Quality Risk Management Plans (QRMP)
• Ensure alignment of study risks with Critical to Quality (CtQ) factors, protocol requirements, and data quality objectives
• Partner closely with Data Management and Biostatistics to define, implement, and monitor KRIs and QTLs
• Lead the execution of centralized monitoring strategies, including ongoing data review, signal detection, and trend analysis
• Provide expert guidance on targeted SDV and targeted SDR approaches based on evolving risk profiles
• Develop and deliver risk analytics, dashboards, and trend presentations to Clinical Project Teams and functional leadership
• Act as the RBQM subject matter expert within Data Management, providing consultation and guidance to cross-functional stakeholders
• Support inspection readiness by ensuring RBQM rationale, documentation, and decisions are inspection-ready and defensible
• Contribute to the continuous improvement of RBQM processes, tools, and standards across Data Management
• Maintain high proficiency in systems and technology as applicable to RBQM monitoring analytics and data access
• Manage direct line reports, providing guidance, mentorship, and performance feedback
Requirements:
• Bachelor's or advanced degree, preferably in life sciences, data analytics/technology, or a related field
• 8+ years of progressive experience in clinical development, data management, clinical quality, or RBQM
• Demonstrated experience supporting or leading oncology clinical trials across Phase 1–4
• Hands-on experience with TransCelerate RBQM frameworks, including RACT and QRMP ownership
• Proven ability to lead risk assessments and influence cross-functional teams without direct authority
• Experience implementing centralized monitoring, KRIs, QTLs, and risk-based SDV/SDR strategies
• Experience operating effectively in a matrixed, global environment
• Experience supporting regulatory inspections or audits related to RBQM
• Familiarity with centralized monitoring platforms and data visualization tools
• Experience contributing to functional or enterprise-level RBQM initiatives
Benefits:
• medical, dental, vision, life and disability insurances
• 401(k) plan
• short incentive plan participation
• flexible paid time off
• 11 paid holidays
• additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter
Apply Now
Apply Now
• Provide study-level leadership for risk-based quality management across Phase 1–4 oncology clinical trials
• Drive data-driven quality oversight, ensuring clinical trial risks are proactively identified, monitored, and mitigated
• Facilitate understanding of the SMPA RBQM Strategy within Clinical Project Teams by providing targeted training sessions
• Lead and facilitate cross-functional risk assessment meetings
• Maintain comprehensive and traceable documentation of all risk assessment activities
• Own the development, maintenance, and ongoing updates of Risk Assessment Categorization Tools (RACT) and Quality Risk Management Plans (QRMP)
• Ensure alignment of study risks with Critical to Quality (CtQ) factors, protocol requirements, and data quality objectives
• Partner closely with Data Management and Biostatistics to define, implement, and monitor KRIs and QTLs
• Lead the execution of centralized monitoring strategies, including ongoing data review, signal detection, and trend analysis
• Provide expert guidance on targeted SDV and targeted SDR approaches based on evolving risk profiles
• Develop and deliver risk analytics, dashboards, and trend presentations to Clinical Project Teams and functional leadership
• Act as the RBQM subject matter expert within Data Management, providing consultation and guidance to cross-functional stakeholders
• Support inspection readiness by ensuring RBQM rationale, documentation, and decisions are inspection-ready and defensible
• Contribute to the continuous improvement of RBQM processes, tools, and standards across Data Management
• Maintain high proficiency in systems and technology as applicable to RBQM monitoring analytics and data access
• Manage direct line reports, providing guidance, mentorship, and performance feedback
Requirements:
• Bachelor's or advanced degree, preferably in life sciences, data analytics/technology, or a related field
• 8+ years of progressive experience in clinical development, data management, clinical quality, or RBQM
• Demonstrated experience supporting or leading oncology clinical trials across Phase 1–4
• Hands-on experience with TransCelerate RBQM frameworks, including RACT and QRMP ownership
• Proven ability to lead risk assessments and influence cross-functional teams without direct authority
• Experience implementing centralized monitoring, KRIs, QTLs, and risk-based SDV/SDR strategies
• Experience operating effectively in a matrixed, global environment
• Experience supporting regulatory inspections or audits related to RBQM
• Familiarity with centralized monitoring platforms and data visualization tools
• Experience contributing to functional or enterprise-level RBQM initiatives
Benefits:
• medical, dental, vision, life and disability insurances
• 401(k) plan
• short incentive plan participation
• flexible paid time off
• 11 paid holidays
• additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter
Apply Now
Apply Now