Sr. Principal Risk Based Quality Management Data Monitor

About This Role As a Senior Principal Risk Based Quality Management Data Monitor, you will be a key contributor to Biogen’s RBQM strategy and process implementation. You will shape how clinical trial data is monitored, protected, and elevated to the highest quality standards, ensuring patient safety, regulatory compliance, and data integrity across all phases of clinical research. You will collaborate 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. What You’ll Do Partner with cross‑functional teams to identify critical data and processes (CDPs) and associated study risks. Contribute to the development and maintenance of study‑specific Risk Assessment Categorization Tool (RACT) or equivalent, providing a clinical data management 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, ensuring timely escalation and follow‑up on any signals or anomalies. Oversee data cleaning timelines and ensure adherence to risk mitigation plans. Review and validate data across EDC, safety, and other clinical systems to ensure consistency and quality. Document and communicate findings clearly to study teams, supporting or triggering 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. Lead process enhancements, technology upgrades, and RBQM best practices; partner with platform/analytics teams to enhance dashboards and detection logic. Provide training, guidance, and mentorship on RBQM concepts to study teams. Who You Are You are a data‑driven problem solver with deep clinical trial operations knowledge. You thrive in fast‑paced, matrixed environments, spot data issues before they escalate, anticipate risk, communicate insights clearly, drive actions, and continuously seek process improvement. You balance rigor with pragmatism, communicate crisply across functions, and stay laser‑focused on patient safety and data integrity. Required Skills & Experience 7+ years in clinical data management, clinical operations, or academia with strong scientific knowledge in at least one therapeutic area within the Biogen portfolio. Experience in RBQM‑focused roles within pharma or CRO settings. Hands‑on experience with centralized monitoring tools (RBQM platforms/dashboards), KRIs, QTLs, or similar methodologies. Proficiency with EDC systems and data visualization tools. High attention to detail and proven ability to manage multiple, competing priorities. Experience supporting audits/inspections and 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. Fluent in English (oral and written). Knowledge of GCP, ICH E6(R2)/E6(R3), regulatory expectations, and industry data quality best practices. Enthusiasm for scientific data excellence and a continuous improvement mindset. 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 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). Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States. #J-18808-Ljbffr Biogen, Inc.