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