Senior Principal Risk- Quality Management Data Monitor

Responsibilities

• Partner with cross‑functional teams to identify critical data and processes (CDPs) and associated study risks
• Contribute significantly to the development and maintenance of the study‑specific Risk Assessment Categorization Tool (RACT) or equivalent by providing a clinical data management focused perspective
• 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
• 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
• Document and communicate findings clearly and effectively to study teams
• Trigger and/or support Corrective and Preventive Actions (CAPA)
• Ensure alignment with ICH‑GCP, FDA/EMA regulations, and internal SOPs
• Support audit and inspection readiness related to RBQM and centralized monitoring
• Contribute to and/or lead process enhancements, technology upgrades, and RBQM best practices
• Provide training, guidance, and mentorship on RBQM concepts to study teams

• 7+ 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