Senior Principal Risk-Based Quality Management Data Monitor

Biogen

. Partner with cross functional teams to identify critical data and processes (CDPs) and associated study risks .

Posted 6/24/2026full-timeResearch Triangle Park • North Carolina • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
Conduct proactive, ongoing data reviews using RBQM dashboards and analytics tools
Ensure timely escalation and follow up on any signals or anomalies
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
Document and communicate findings clearly and effectively to study teams
Trigger and/or support Corrective and Preventive Actions (CAPA)
Ensure alignment with ICH‑GCP, FDA/EMA regulations, and internal SOPs
Support audit and inspection readiness related to RBQM and centralized monitoring
Contribute to and/or lead process enhancements, technology upgrades, and RBQM best practices
Provide training, guidance, and mentorship on RBQM concepts to study teams.

Requirements

What you’ll need

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
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.

Benefits

Comp & perks

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

ATS Keywords

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Hard Skills & Tools

clinical data managementrisk assessmentdata cleaningdata validationdata visualizationregulatory compliancerisk-based quality management (RBQM)data analyticscorrective and preventive actions (CAPA)study endpoints

Soft Skills

attention to detailanalytical thinkingcritical thinkingcommunicationstakeholder managementadaptabilityproblem-solvingcollaborationmentorshiptime management