Sr. Principal Risk 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.

• 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).

• 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.

• Medical, Dental, Vision, & Life insurances; fitness/wellness reimbursement; short- and long-term disability; paid vacation (minimum 15 days) and end-of-year shutdown (Dec
  26–Dec
  31); 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.