Not specified; short-term incentive plan (mip) eli...
Full-time, flexible work arrangement with 15% travel.
5 years j-gcp/iso14155 experience
3 years external supplier management
Project management experience
Medtronic Diabetes is seeking a Clinical Study Manager in Tokyo to oversee and manage clinical studies, ensuring compliance with regulatory requirements while collaborating with various stakeholders. The ideal candidate should have extensive experience in clinical trials, project management, and knowledge of medical devices and regulations
Job Summary
The role involves leading clinical teams to execute domestic and global clinical trials for medical devices while ensuring regulatory compliance with PMDA standards.
Candidates will be responsible for developing study strategies, managing budgets, selecting external suppliers, and negotiating with government agencies and investigators throughout the trial lifecycle.
Medtronic offers comprehensive benefits including up to 360,000 yen in childcare subsidies, flexible work arrangements, and a commitment to employee growth through mentorship programs.
Matching Summary
Match Score: 85
Medtronic Diabetes is seeking a Clinical Study Manager in Tokyo to oversee and manage clinical studies, ensuring compliance with regulatory requirements while collaborating with various stakeholders. The ideal candidate should have extensive experience in clinical trials, project management, and knowledge of medical devices and regulations.
Salary
Not specified; Short-term incentive plan (MIP) eligible; Competitive salary and flexible benefits package
Skills & Requirements
Must-have
5 years J-GCP/ISO14155 experience
3 years external supplier management
Project management experience
Bachelor's degree required
Native Japanese language skills
Business level English proficiency
Nice-to-have
Medical field background (nurse/pharmacist)
PMDA GCP conformity inspection experience
CRA experience preferred
Master's or Doctorate in science
Statistical analysis knowledge
Data management expertise
Key Requirements
Minimum 5 years of J-GCP/ISO14155 related work experience