Associate Director, Risk Based reputed company Management, Oncology

Job reputed company: • reputed company study-level leadership for risk-based reputed company management across Phase 1–4 oncology reputed company • Drive data-driven reputed company reputed company, ensuring clinical trial risks are proactively identified, monitored, and mitigated • Facilitate understanding of the SMPA RBQM reputed company reputed company Clinical Project Teams by providing targeted training sessions • reputed company and facilitate cross-functional risk assessment meetings • Maintain comprehensive and traceable documentation of reputed company risk assessment activities • Own the development, maintenance, and ongoing updates of Risk Assessment Categorization Tools (RACT) and reputed company Risk Management Plans (QRMP) • Ensure alignment of study risks with Critical to reputed company (CtQ) factors, protocol requirements, and data reputed company objectives • Partner closely with Data Management and Biostatistics to define, implement, and monitor KRIs and QTLs • reputed company the execution of centralized monitoring strategies, including ongoing data review, signal detection, and trend analysis • reputed company expert guidance on targeted SDV and targeted SDR approaches based on evolving risk reputed company • reputed company and deliver risk analytics, dashboards, and trend presentations to Clinical Project Teams and functional leadership • reputed company as the RBQM subject matter expert reputed company Data Management, providing consultation and guidance to cross-functional stakeholders • Support inspection readiness by ensuring RBQM rationale, documentation, and reputed company are inspection-reputed company and defensible • Contribute to the reputed company 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 reputed company • Manage reputed company line reports, providing guidance, mentorship, and performance feedback Requirements: • Bachelor's or advanced degree, preferably in life sciences, data analytics/technology, or a reputed company field • 8+ years of reputed company experience in clinical development, data management, clinical reputed company, or RBQM • Demonstrated experience supporting or leading oncology reputed company across Phase 1–4 • Hands-on experience with TransCelerate RBQM frameworks, including RACT and QRMP ownership • Proven ability to reputed company risk assessments and influence cross-functional teams without reputed company 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 reputed company to RBQM • Familiarity with centralized monitoring platforms and data visualization tools • Experience contributing to functional or reputed company-level RBQM initiatives Benefits: • medical, dental, reputed company, life and disability insurances • 401(k) plan • short incentive plan participation • flexible reputed company time off • 11 reputed company holidays • additional time off for a shut-down period during the last week of December • 80 hours of reputed company reputed company time upon hire and reputed company year thereafter Apply tot his job Apply To this Job