Principal Risk Based Quality Management Data Monitor

Responsibilities

• Partner with cross functional teams to identify critical data and processes (CDPs) and associated study risks
• Support the development and maintenance of the study-specific Risk Assessment Categorization Tool (RACT) or equivalent
• Prioritize risks and signals based on patient safety impact, data integrity, severity, likelihood, and detectability
• Conduct proactive, ongoing data reviews using RBQM dashboards and analytics tools
• Ensure timely escalation and follow up on any signals or anomalies
• Triaging: prioritize, escalate, and track signals
• Review and validate data across EDC, safety, and other clinical systems to ensure consistency and quality
• Oversee data cleaning timelines and ensure adherence to risk mitigation plans
• Partner with study teams to ensure data flow mapping supports early risk detection
• Document and communicate findings clearly and effectively to study teams
• Trigger or support Corrective and Preventive Actions (CAPA)
• Participate in root cause analyses for major deviations or quality concerns
• Ensure alignment with ICH-GCP, FDA/EMA regulations, and internal SOPs.
• Support audit and inspection readiness related to RBQM and centralized monitoring
• -Technology Enablement & Continuous Improvement
• Contribute to process enhancements, technology upgrades, and RBQM best practices
• Partner with platform/analytics teams to enhance dashboards and detection logic; perform UAT and help shape product roadmaps
• Provide training, guidance, and mentorship on RBQM concepts to study teams.

Requirements

• Required Skills
• 5+ years of experience in clinical data management, clinical operations or Academia with strong scientific knowledge in at least one therapeutic area within the Biogen portfolio
• RBQM-focused roles within pharma or CRO settings
• Hands-on experience with centralized monitoring tools (RBQM platforms/dashboards), KRIs, QTLs, or similar RBQM methodologies
• Proficiency with EDC systems and data visualization tools
• High attention to detail including proven ability to manage multiple, competing priorities
• Experience supporting audits/inspections
• Understanding of clinical data flow, study endpoints, and regulatory requirements
• -Strong analytical and critical-thinking abilities
• -Excellent communication and stakeholder management skills
• Ability to adapt and thrive in a dynamic, cross-functional environment
• Risk-based thinking & structured problem-solving
• Data driven decision-making
• -Collaborative teamwork across clinical and operational functions
• -Deep understanding of drug development and biopharmaceutical industry required
• Fluent English (oral and written)
• -Demonstrated ability to identify data trends, signals, outliers, and risk indicators using listings, visualizations, metrics, and analytics tools
• -Strong knowledge of GCP, ICH E6(R2)/E6(R3), regulatory expectations, and industry data quality best practices
• -Demonstrated problem-solving skills with a continuous improvement mindset and enthusiasm for scientific data excellence.
• Education Requirements/Preferred Skills
• Bachelor's degree in life sciences, health sciences, pharmacy, nursing, data science, or related discipline; advanced degree (MS, PharmD, PhD) strongly preferred
• Experience with implementing consistent clinical and scientific data review processes
• Experience defining and calibrating KRIs/QTLs at study and portfolio levels
• Experience with cross study trending and systemic risk analysis
• Therapeutic area familiarity aligned to portfolio (e.g., neuroscience, rare disease, immunology)
• Job Level: Management
• Additional Information
• The base compensation range for this role is: $116,000.00-$155,000

Benefits

Additional Information

About This Role As a Principal Risk Based Quality Management Data Monitor, you will play a critical role in shaping how clinical trial data is monitored, protected, and elevated to the highest quality standards. You will be at the forefront of implementing Risk-Based Quality Management (RBQM) strategies-ensuring patient safety, regulatory compliance, and data integrity across all phases of clinical research. You'll collaborate closely with biostatistics, data science, safety/pharmacovigilance, clinical operations, and vendors to detect and triage signals early, optimize KRIs/QTLs, and drive continuous process and technology improvements across the portfolio. This position is ideal for someone who thrives on analytical thinking, cross-functional collaboration, and using RBQM and advanced analytics to keep clinical trials running smoothly and safely.

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