Principal Risk Based Quality Management Data Monitor
Biogen
6 days ago
Remote friendly (Triangle, NC)
United States
Operations
What You’ll Do
- Partner with cross-functional teams to identify critical data/processes (CDPs) and study risks.
- Support development/maintenance of the study Risk Assessment Categorization Tool (RACT) or equivalent.
- Prioritize risks/signals by patient safety impact, data integrity, severity/likelihood/detectability; triage, escalate, and track signals.
- Conduct proactive, ongoing RBQM data reviews using dashboards/analytics.
- Ensure timely escalation/follow-up on signals/anomalies.
- Review/validate data across EDC, safety, and other systems for consistency and quality.
- Oversee data-cleaning timelines and adherence to risk mitigation plans.
- Support data flow mapping for early risk detection; document/communicate findings.
- Trigger/support CAPA; participate in root cause analyses for deviations/quality concerns.
- Ensure alignment with ICH-GCP and FDA/EMA regulations and internal SOPs.
- Support audit/inspection readiness for RBQM and centralized monitoring.
- Contribute to process enhancements and RBQM best practices; enhance dashboards/detection logic, perform UAT, and support roadmaps.
- Train/mentor study teams on RBQM concepts.
Required Skills
- 5+ years in clinical data management, clinical operations, or academia (strong scientific knowledge in at least one therapeutic area).
- RBQM experience in pharma/CRO; centralized monitoring tools (RBQM platforms/dashboards), KRIs/QTLs.
- Proficiency with EDC systems and data visualization; strong analytical/critical thinking.
- Audit/inspection support; understanding clinical data flow/endpoints and regulatory requirements.
- Strong communication/stakeholder management; English (oral/written); GCP/ICH E6(R2)/E6(R3) knowledge; risk-based thinking.
Education / Preferred Skills
- Bachelor’s in life/health sciences, pharmacy, nursing, data science, or related; MS/PhD/PharmD strongly preferred.
- Experience implementing data review processes; defining/calibrating KRIs/QTLs; cross-study trending/systemic risk analysis; portfolio-aligned therapeutic area familiarity.
Benefits (explicit)
- Medical, dental, vision, life; fitness/wellness reimbursement; short- and long-term disability; 15+ days paid vacation; paid holidays; sick time; paid maternity/parental leave; 401(k) match; stock purchase; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
- Partner with cross-functional teams to identify critical data/processes (CDPs) and study risks.
- Support development/maintenance of the study Risk Assessment Categorization Tool (RACT) or equivalent.
- Prioritize risks/signals by patient safety impact, data integrity, severity/likelihood/detectability; triage, escalate, and track signals.
- Conduct proactive, ongoing RBQM data reviews using dashboards/analytics.
- Ensure timely escalation/follow-up on signals/anomalies.
- Review/validate data across EDC, safety, and other systems for consistency and quality.
- Oversee data-cleaning timelines and adherence to risk mitigation plans.
- Support data flow mapping for early risk detection; document/communicate findings.
- Trigger/support CAPA; participate in root cause analyses for deviations/quality concerns.
- Ensure alignment with ICH-GCP and FDA/EMA regulations and internal SOPs.
- Support audit/inspection readiness for RBQM and centralized monitoring.
- Contribute to process enhancements and RBQM best practices; enhance dashboards/detection logic, perform UAT, and support roadmaps.
- Train/mentor study teams on RBQM concepts.
Required Skills
- 5+ years in clinical data management, clinical operations, or academia (strong scientific knowledge in at least one therapeutic area).
- RBQM experience in pharma/CRO; centralized monitoring tools (RBQM platforms/dashboards), KRIs/QTLs.
- Proficiency with EDC systems and data visualization; strong analytical/critical thinking.
- Audit/inspection support; understanding clinical data flow/endpoints and regulatory requirements.
- Strong communication/stakeholder management; English (oral/written); GCP/ICH E6(R2)/E6(R3) knowledge; risk-based thinking.
Education / Preferred Skills
- Bachelor’s in life/health sciences, pharmacy, nursing, data science, or related; MS/PhD/PharmD strongly preferred.
- Experience implementing data review processes; defining/calibrating KRIs/QTLs; cross-study trending/systemic risk analysis; portfolio-aligned therapeutic area familiarity.
Benefits (explicit)
- Medical, dental, vision, life; fitness/wellness reimbursement; short- and long-term disability; 15+ days paid vacation; paid holidays; sick time; paid maternity/parental leave; 401(k) match; stock purchase; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.