Clinical Quality Lead

argenx.nl

Base: $152,000.00 - $209,000.00 usd; bonus/equity:...
Onsite
Gcp oversight for clinical trials
Gcp sme
Audit and inspection planning
The Clinical Quality Lead is responsible for driving towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing

Job Summary

  • The Clinical Quality Lead is responsible for driving towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing.
  • Serve as the primary Quality point of contact for assigned clinical trials and guide the Clinical Trial Team (CTT) to ensure clinical trials are conducted in compliance with GCPs, regulatory requirements, and argenx processes.
  • The annual base salary hiring range for this position is $152,000.00 - $209,000.00 USD, and the job is eligible to participate in short-term and long-term incentive programs.

Matching Summary

The Clinical Quality Lead is responsible for driving towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing.

Salary

Base: $152,000.00 - $209,000.00 USD; Bonus/Equity: Eligible for short-term and long-term incentive programs; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • GCP oversight for clinical trials
  • GCP SME
  • audit and inspection planning
  • clinical quality event investigations
  • vendor relationship management
  • GCP Quality Point of Contact

Nice-to-have

  • Inspire and grow company
  • Thrive in dynamic environment
  • Influence without direct leadership
  • Continuous improvement mindset

Key Requirements

  • Minimum 7 years clinical trial experience
  • Minimum 5 years quality assurance experience
  • MS Degree
  • FDA, EMA, MHRA, PDMA Inspection experience

Work Rights

Not specified

Tailored Resume

Cover Letter