Principal Cra – Lead Monitor (m/w/d)

Thermo Fisher Scientific UK

Germany
Hybrid
Clinical monitoring and site management
Ich-gcp and regulatory compliance
Risk-based monitoring approach
Enable customers to make the world healthier, cleaner and safer through PPD® clinical research services

Job Summary

  • Enable customers to make the world healthier, cleaner and safer through PPD® clinical research services.
  • Lead and coordinate all aspects of clinical monitoring and site management for complex clinical trials, ensuring subject safety and data integrity.
  • Actively mentor, coach, and support the development of junior and senior CRAs, and contribute to project-specific and functional training initiatives.

Matching Summary

Enable customers to make the world healthier, cleaner and safer through PPD® clinical research services.

Skills & Requirements

Must-have

  • Clinical monitoring and site management
  • ICH-GCP and regulatory compliance
  • Risk-based monitoring approach
  • Root cause analysis
  • Investigational product accountability
  • Site initiation, maintenance, and close-out

Nice-to-have

  • Mentoring and coaching junior CRAs
  • Process optimization and implementation
  • Strategic recommendations to CTM
  • Flexibility and adaptability

Key Requirements

  • Minimum 5+ years experience as CRA/Monitor
  • Bachelor's degree in life sciences or equivalent
  • Full right to work in Germany
  • Fluency in German and English (C1)

Work Rights

Full right to work in Germany

Tailored Resume

Cover Letter