Position Job Title: Senior Principal Risk Based Quality Management Data Monitor
Location: Research Triangle Park, NC (preferred, not mandatory)
About This Role
As 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 Do
Risk Identification & Assessment
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
Centralized Monitoring
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
Data Quality Oversight
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
Issue Management
Document and communicate findings clearly and effectively to study teams
Trigger and/or support Corrective and Preventive Actions (CAPA)
Participate in root cause analyses for major deviations or quality concerns
Compliance & Governance
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 and/or lead 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.
Who You Are
You'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 Skills
Education Requirements/Preferred Skills
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: Management
Additional Information
The 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 both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
Why Biogen?
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. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.
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.