Biogen
Sr. Principal Risk Based Quality Management Data Monitor
Research Triangle Park, NC · Principal
Sponsorship not specifiedDetected 27 days ago
GCPData ScienceData VisualizationDetection EngineeringComplianceStakeholder ManagementExcelClinical TrialsFDA RegulatoryPharmacovigilanceResearchCommunicationCollaborationProblem SolvingMentoringBiostatistics
About the role
- Position Job Title: Senior Principal Risk Based Quality Management Data Monitor
- Location: Research Triangle Park, NC (preferred, not mandatory)
Responsibilities
- Partner with cross functional teams to identify critical data and processes (CDPs) and associated study risks
- Review and validate data across EDC, safety, and other clinical systems to ensure consistency and quality
- Partner with study teams to ensure data flow mapping supports early risk detection
- Document and communicate findings clearly and effectively to study teams
- Trigger and/or support Corrective and Preventive Actions (CAPA)
- Support audit and inspection readiness related to RBQM and centralized monitoring
Requirements
- You can spot data issues before they escalate.
- 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
- Hands-on experience with centralized monitoring tools (RBQM platforms/dashboards), KRIs, QTLs, or similar RBQM methodologies
- Proficiency with EDC systems and data visualization tools
- Experience supporting audits/inspections
Nice to have
- Research Triangle Park, NC (preferred, not mandatory)
- As a Senior Principal Risk Based Quality Management Data Monitor, y ou 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.
- 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.
Compensation
- 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.
- Tuition reimbursement of up to $10,000 per calendar year
Company info
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- We are a global team with a commitment to excellence, and a pioneering spirit.
- As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.