Principal Risk Based Quality Management Data Monitor

Principal Risk Based Quality Management Data Monitor

As a Principal Risk Based Quality Management Data Monitor, 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

• Partner with cross functional teams to identify critical data and processes (CDPs) and associated study risks
• Support the development and maintenance of the study-specific Risk Assessment Categorization Tool (RACT) or equivalent
• 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
• Triaging: prioritize, escalate, and track signals
• 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
• Document and communicate findings clearly and effectively to study teams
• Trigger or support 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
• Technology Enablement & Continuous Improvement
• Contribute to 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

• 5+ 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.

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 with 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)

Job Level: Management

Additional Information

The base compensation range for this role is: $116,000.00-$155,000.00

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:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

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.