Associate Director, RBQM Data Enablement and Analytics

Role: Senior RBQM Data Enablement Lead responsible for configuring and managing Centralized Monitoring platforms, translating risk assessments into system specifications, and driving continuous process improvements in Risk Based Quality Management (RBQM) within clinical trials. Responsibilities include overseeing data flows across systems, supporting technology releases, managing vendor relationships, and serving as subject matter expert on RBQM technology and signal interpretation. Requirements: minimum 8 years in pharma or CRO, at least 3 years in RBQM, and 2+ years of managerial experience; strong understanding of drug development, GxP standards, and regulatory compliance (e.g., 21 CFR Part 11, ICH E6). Preferred skills include expertise in risk management, data analytics, and cross-functional leadership, with proficiency in RBQM IT systems. High-Value: focus on clinical trial data enablement, risk-based monitoring, and technology governance; virtual work setup in Massachusetts with no travel specified.