Sr. Principal Risk Based Quality Management Data Monitor
Core
Senior leader shaping Biogen's Risk-Based Quality Management (RBQM) strategy to ensure clinical trial data integrity, patient safety, and regulatory compliance across all research phases.
Role type
Senior Principal Risk Based Quality Management Data Monitor (Strategy & Operations)
Builds
RBQM strategies, centralized monitoring dashboards, and risk assessment tools for clinical trials
Domain
Biopharmaceuticals / Clinical Research / Data Quality
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
RBQM strategy implementation, centralized monitoring, KRI/QTL definition, EDC system proficiency, regulatory compliance (ICH-GCP/FDA/EMA), root cause analysis, cross-functional collaboration, data visualization, therapeutic area expertise, process improvement
Preferred skills
Advanced degree (MS/PhD), portfolio-level risk analysis, systemic risk analysis, UAT for analytics platforms
Technologies
RBQM platforms, EDC systems, data visualization tools
Responsibilities
Develop RBQM strategy and processes, identify and prioritize study risks, conduct centralized monitoring via dashboards, validate data across clinical systems, manage CAPA and root cause analyses, ensure audit readiness, mentor study teams on RBQM concepts
Seniority
Senior, hands-on IC with strategic influence
