Associate Director, Risk Based Quality Management Lead

Role: Associate Director, Risk-Based Quality Management (RBQM) Lead for clinical trials in Summit’s oncology portfolio, including Phase 3 studies in NSCLC and CRC. Responsibilities: lead study-level RBQM planning, risk assessments, and centralized monitoring; develop and maintain risk management tools like KRIs and QTLs; oversee site risk surveillance, issue investigations, and CAPA processes; facilitate risk review meetings; ensure inspection readiness and regulatory compliance. Requirements: 10+ years of clinical operations experience, with 7+ years in RBQM, centralized monitoring, or study management; strong background supporting global Phase II/III oncology trials; expertise in risk assessment, KRIs, QTLs, and risk-based monitoring platforms; deep knowledge of GCP, ICH, and FDA regulations; bachelor’s degree in life sciences or related field. HighValue: oncology (NSCLC, CRC), Phase 3, risk-based monitoring, centralized data review, CRO collaboration, GCP/ICH/FDA compliance. WorkSetup: full-time, based in Miami, with extensive cross-functional stakeholder engagement.