Sr. Principal Risk Based Quality Management Data Monitor

Position Job Title: Senior Principal Risk Based Quality Management Data Monitor Location: Research Triangle Park, NC (preferred, not mandatory)About This RoleAs a Senior Principal Risk Based Quality Management Data Monitor, you will be a key contributor to the creation of Biogen’s in-house RBQM strategy and process implementation. 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.What You’ll DoRisk Identification & AssessmentPartner with cross functional teams to identify critical data and processes (CDPs) and associated study risksContribute significantly to the development and maintenance of the study-specific Risk Assessment Categorization Tool (RACT) or equivalent by providing a clinical data management focused perspectivePrioritize risks and signals based on patient safety impact, data integrity, severity, likelihood, and detectabilityCentralized MonitoringConduct proactive, ongoing data reviews using RBQM dashboards and analytics toolsEnsure timely escalation and follow up on any signals or anomaliesTriaging: Prioritize, Escalate, and Track signalsData Quality OversightReview and validate data across EDC, safety, and other clinical systems to ensure consistency and qualityOversee data cleaning timelines and ensure adherence to risk mitigation plansPartner with study teams to ensure data flow mapping supports early risk detectionIssue ManagementDocument and communicate findings clearly and effectively to study teamsTrigger and/or support Corrective and Preventive Actions (CAPA)Participate in root cause analyses for major deviations or quality concernsCompliance & GovernanceEnsure alignment with ICH‑GCP, FDA/EMA regulations, and internal SOPs.Support audit and inspection readiness related to RBQM and centralized monitoringTechnology Enablement & Continuous ImprovementContribute to and/or lead process enhancements, technology upgrades, and RBQM best practicesPartner with platform/analytics teams to enhance dashboards and detection logic; perform UAT and help shape product roadmapsProvide training, guidance, and mentorship on RBQM concepts to study teams.Who You AreYou’re a data-driven problem solver with a deep understanding of clinical trial operations. You excel in fast-paced, matrixed environments and are energized by collaborating with diverse teams. You can spot data issues before they escalate. You anticipate risk, communicate insights clearly, drive actions, and continuously look for ways to improve processes. You balance rigor with pragmatism, communicate crisply across functions, and stay laser focused on patient safety and data integrity.Required Skills7+ years of experience in clinical data management, clinical operations or Academia with strong scientific knowledge in at least one therapeutic area within the Biogen portfolioRBQM-focused roles within pharma or CRO settingsHands-on experience with centralized monitoring tools (RBQM platforms/dashboards), KRIs, QTLs, or similar RBQM methodologiesProficiency with EDC systems and data visualization toolsHigh attention to detail including proven ability to manage multiple, competing prioritiesExperience supporting audits/inspectionsUnderstanding of clinical data flow, study endpoints, and regulatory requirementsStrong analytical and critical-thinking abilitiesExcellent communication and stakeholder management skillsAbility to adapt and thrive in a dynamic, cross-functional environmentRisk-based thinking & structured problem-solvingData driven decision-makingCollaborative teamwork across clinical and operational functionsDeep understanding of drug development and biopharmaceutical industry requiredFluent English (oral and written)Demonstrated ability to identify data trends, signals, outliers, and risk indicators using listings, visualizations, metrics, and analytics toolsStrong knowledge of GCP, ICH E6(R2)/E6(R3), regulatory expectations, and industry data quality best practicesDemonstrated problem-solving skills with a continuous improvement mindset and enthusiasm for scientific data excellence.Education Requirements/Preferred SkillsBachelor’s degree in life sciences, health sciences, pharmacy, nursing, data science, or related discipline; advanced degree (MS, PharmD, PhD) strongly preferredExperience with implementing consistent clinical and scientific data review processesExperience defining and calibrating KRIs/QTLs at study and portfolio levelsExperience with cross study trending and systemic risk analysisTherapeutic area familiarity aligned to portfolio (e.g., neuroscience, rare disease, immunology)Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry, and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. Job Level: ManagementAdditional InformationThe base compensation range for this role is: -Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.Regular employees are eligible to receive