Principal Risk Based Quality Management Data Monitor

Biogen•Research Triangle Park, NC

1d•$116,000 - $155,000

About The Position

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.

Requirements

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

Nice To Haves

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)

Responsibilities

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
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

Benefits

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