Principal Risk Based Quality Management Data Monitor

Biogen

Research Triangle Park, NC, United States
Base: $116,000.00-$155,000.00; bonus/equity: cash ...
Risk-based quality management (rbqm)
Clinical trial data monitoring
Centralized monitoring tools
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

Job Summary

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

Matching Summary

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.

Salary

Base: $116,000.00-$155,000.00; Bonus/Equity: cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, & Life insurances, Fitness & Wellness programs, Disability insurance, Paid time off, Holidays, 401(k) program, ESPP, Tuition reimbursement

Skills & Requirements

Must-have

  • Risk-Based Quality Management (RBQM)
  • clinical trial data monitoring
  • centralized monitoring tools
  • EDC systems and data visualization
  • ICH-GCP, FDA/EMA regulations
  • data integrity and patient safety

Nice-to-have

  • analytical thinking and collaboration
  • continuous process and technology improvements
  • cross-functional collaboration
  • data-driven problem solver
  • scientific data excellence

Key Requirements

  • 5+ years of experience
  • Bachelor's degree in life sciences or related discipline
  • Advanced degree (MS, PharmD, PhD) strongly preferred
  • Fluent English (oral and written)

Work Rights

Not specified

Tailored Resume

Cover Letter