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
Job Summary
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.
Biogen offers a full and highly competitive range of benefits designed to support employees’ and their families physical, financial, emotional, and social well-being.
The company fosters an environment where individual contributions make a significant impact and provides unparalleled opportunities for learning, growth, and expanding skills.
Matching Summary
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.
Salary
Base: $116,000.00-$155,000.00; Bonus/Equity: Cash bonus and equity incentives available; Benefits: Medical, Dental, Vision, Life insurance, 401(k) with match, paid time off, parental leave, tuition reimbursement
Skills & Requirements
Must-have
Risk-Based Quality Management (RBQM)
Centralized monitoring tools and dashboards
Clinical data management and operations
KRIs and QTLs optimization
Regulatory compliance with ICH-GCP and FDA/EMA
Data visualization and EDC systems proficiency
Cross-functional collaboration
Nice-to-have
Process and technology continuous improvement
Training and mentorship on RBQM concepts
Scientific data excellence mindset
Strong stakeholder management skills
Adaptability in dynamic environments
Data-driven decision-making
Therapeutic area familiarity aligned to portfolio
Key Requirements
5+ years clinical data management or operations experience
Experience in RBQM roles within pharma or CRO
Bachelor’s degree in life sciences or related field; advanced degree preferred
Experience supporting audits and inspections
Strong knowledge of GCP, ICH E6(R2)/E6(R3), and regulatory expectations
Therapeutic area experience aligned to Biogen portfolio