Principal Risk Based Quality Management Data Monitor

Biogen

Base: $116,000.00-$155,000.00; bonus/equity: short...
5+ years clinical data management experience
Rbqm methodology and centralized monitoring tools
Edc systems proficiency and data visualization
This role is critical for shaping how clinical trial data is monitored, protected, and elevated to the highest quality standards through Risk-Based Quality Management strategies

Job Summary

  • This role is critical for shaping how clinical trial data is monitored, protected, and elevated to the highest quality standards through Risk-Based Quality Management strategies.
  • The position requires partnering with cross-functional teams to identify critical data processes, prioritize risks based on patient safety impact, and drive continuous technology improvements.
  • Biogen offers a competitive benefits package including up to $10,000 in tuition reimbursement, equity incentives, and comprehensive health and wellness programs.

Matching Summary

This role is critical for shaping how clinical trial data is monitored, protected, and elevated to the highest quality standards through Risk-Based Quality Management strategies.

Salary

Base: $116,000.00-$155,000.00; Bonus/Equity: Short-term cash bonus and equity incentive opportunities available; Benefits: Medical, Dental, Vision, Life insurance, 401(k) match, and tuition reimbursement up to $10,000

Skills & Requirements

Must-have

  • 5+ years clinical data management experience
  • RBQM methodology and centralized monitoring tools
  • EDC systems proficiency and data visualization
  • ICH-GCP and FDA/EMA regulatory knowledge
  • KRI/QTL development and risk assessment

Nice-to-have

  • Cross-functional collaboration in matrixed environments
  • Continuous improvement and process optimization mindset
  • Therapeutic area familiarity in neuroscience or rare disease
  • Mentorship and training capabilities for study teams
  • Experience with root cause analysis for deviations

Key Requirements

  • Bachelor's degree in life sciences or related field (MS/PhD preferred)
  • 5+ years of experience in clinical operations or data management
  • Fluent English oral and written communication skills
  • Demonstrated ability to support audits and inspections

Work Rights

Not specified

Tailored Resume

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