Clinical Study (project) Manager (crms @ Tokyo)

Medtronic UK

Tokyo, Japan
Competitive salary; short-term incentive plan (mip...
5 years j-gcp/iso14155 experience
3 years external supplier management
Project management in clinical research
The role involves leading clinical teams to execute pre-market and post-market studies for new medical devices while ensuring compliance with Japanese regulations

Job Summary

  • The role involves leading clinical teams to execute pre-market and post-market studies for new medical devices while ensuring compliance with Japanese regulations.
  • Candidates will negotiate study progress and execution plans with stakeholders including the PMDA, investigators, and external suppliers throughout the entire trial lifecycle.
  • Medtronic offers comprehensive benefits including up to 360,000 yen in annual childcare subsidies and flexible work arrangements with only 15% travel required.

Matching Summary

The role involves leading clinical teams to execute pre-market and post-market studies for new medical devices while ensuring compliance with Japanese regulations.

Salary

Competitive salary; Short-term incentive plan (MIP) available; Comprehensive benefits package including childcare subsidies

Skills & Requirements

Must-have

  • 5 years J-GCP/ISO14155 experience
  • 3 years external supplier management
  • Project management in clinical research
  • Native Japanese language proficiency
  • Business level English communication

Nice-to-have

  • Nurse or pharmacist background
  • PMDA GCP conformity inspection experience
  • CRA experience in clinical monitoring
  • Knowledge of medical devices and diseases
  • Master's or Doctorate in scientific field

Key Requirements

  • Bachelor's degree required
  • TOEIC score around 800
  • Experience with Clinical Trial Acts
  • Ethical Guidelines knowledge
  • Statistical analysis knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter