Sr. Principal Risk Based Quality Management Data Monitor

What You’ll Do Risk Identification & Assessment: Partner with cross-functional teams to identify critical data/processes (CDPs) and associated study risks; maintain the study-specific Risk Assessment Categorization Tool (RACT) or equivalent; prioritize risks/signals by patient safety impact, data integrity, severity, likelihood, and detectability. Centralized Monitoring: Conduct proactive, ongoing data reviews using RBQM dashboards/analytics tools; ensure timely escalation/follow-up on signals/anomalies; prioritize/escalate/track signals. Data Quality Oversight: Review/validate data across EDC, safety, and other clinical systems for consistency/quality; oversee data-cleaning timelines and adherence to risk mitigation plans; ensure data flow mapping supports early risk detection. Issue Management: Document/communicate findings; trigger/support Corrective and Preventive Actions (CAPA); participate in root cause analyses. Compliance & Governance: Ensure alignment with ICH-GCP, FDA/EMA regulations, and internal SOPs; support audit/inspection readiness for RBQM and centralized monitoring. Technology Enablement & Continuous Improvement: Lead process enhancements/technology upgrades; improve dashboards/detection logic (UAT, roadmaps); train/mentor study teams. Required Skills 7+ years in clinical data management, clinical operations, or academia with strong scientific knowledge in a Biogen therapeutic area; RBQM-focused pharma/CRO experience. Hands‑on centralized monitoring (RBQM platforms/dashboards), KRIs/QTLs; EDC and data visualization proficiency. Audit/inspection support; strong analytical, critical thinking, risk-based problem‑solving, communication, stakeholder management; GCP/ICH E6(R2)/E6(R3) knowledge; English (oral/written). Education / Preferred Skills Bachelor’s in life sciences/health sciences/pharmacy/nursing/data science (MS/PharmD/PhD strongly preferred). Experience with consistent clinical/scientific review processes; define/calibrate KRIs/QTLs; cross-study trending/systemic risk analysis; therapeutic area familiarity. Benefits Medical, Dental, Vision, & Life insurances; fitness/wellness reimbursement; short- and long-term disability; paid vacation (minimum 15 days) and end-of-year shutdown (Dec26–Dec31); up to 12 paid holidays + 3 personal significance days; 80 hours sick time/year; paid maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation. #J-18808-Ljbffr Scorpion Therapeutics