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About the Role
This role is central to clinical research projects, including post-market surveillance, post-market clinical research, and investigator-initiated clinical studies. You will manage and operate teams according to relevant regulations and internal SOPs, and collaborate with external and internal stakeholders to develop publication and regulatory strategies for clinical research findings. Additionally, you will provide guidance, coaching, and training to internal and external parties.
Responsibilities
- Manage and operate teams according to relevant regulations and internal SOPs.
- Manage budgets, including selection of research facilities and vendors.
- Collaborate with vendors, government officials (e.g., PMDA), and healthcare professionals.
- Collaborate with quality assurance and regulatory affairs departments.
- Develop publication strategies for clinical research findings (e.g., conference presentations, journal publications).
- Develop regulatory strategies utilizing clinical research findings.
- Provide guidance, coaching, and training on clinical research matters to internal and external stakeholders.
- Manage and operate teams for post-market surveillance, post-market clinical research, and investigator-initiated clinical studies.
Requirements
- Over 5 years of experience in roles related to J-GCP/ISO14155, ethical guidelines for medical research involving human subjects, and the Clinical Research Act.
- Over 3 years of experience managing external suppliers (e.g., CROs, SMOs).
- Project management experience or lead monitor experience.
- Experience in the medical field (e.g., nurse, pharmacist, technician) is recommended.
- Experience in clinical development or equivalent is recommended.
- Experience with PMDA GCP compliance inspections is recommended.
- CRA experience is recommended.
- Knowledge of devices and diseases is recommended.
Skills
- High communication skills, including the ability to accept different opinions.
- High problem-solving and information analysis skills.
- Logical thinking.
- Business thinking with compliance and quality in mind.
- Business-level English (approx. TOEIC 730).
- Native-level Japanese.
- Familiarity with J-GCP/ISO14155.
- Knowledge of ethical guidelines for medical research involving human subjects, the Clinical Research Act, and other related notifications.
- Statistical analysis is recommended.
- Data management is recommended.
Location
- Japan
Work Type
- Full-time
Experience Level
- 5+ years of experience in J-GCP/ISO14155, ethical guidelines, and Clinical Research Act.
- 3+ years of experience managing external suppliers.
- Project management or lead monitor experience.
Education Level
- Bachelor's degree.
- PhD or Master's degree in a science field is recommended.
Salary/Compensations
- Competitive Salary
Benefits
- Flexible Benefits Package
- Medtronic Incentive Plan (MIP)
About the Company
- Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life.
- Our 95,000 employees work across more than 150 countries.
- We develop innovative medical technologies that improve the lives of 72+ million patients each year.
Equal Opportunity
- Medtronic offers a competitive Salary and flexible Benefits Package
- A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.