Job summary
Job category | Professional (Consulting / Finance / Real Estate / Professional Services)/Professional Services (Health Care / Welfare / Education / Instruction) |
---|---|
Industry | Health Care/ Medical Equipment |
Employment type | Uncategorized |
Position level | Other |
Number of openings | 1 |
Desired entry time | - |
Required language skill |
Japanese (Fluent) English (Business) |
Foreign language competence | - |
Working hours | Others |
Welfares / Leave systems | |
Assistance in visa application | - |
Number of foreign employees | - |
Work details
Company Overview
Medical Devices
Job Description
- Ensure execution of a clinical study within timeline and on budget, utilizing and overseeing CRO
- Planning and management of budget for clinical study
- Ensure execution of PMDA consultation
- Write full of protocol and IB based on approved synopsis and CE technical documents.
- Develop quality supporting documents, e.g., manual of operations, informed consent
- Ensure Health Authority and IRB submission and approval
- Participate in site selection and evaluation process
Requirements
Minimum: 3+ years experience of clinical trial, Knowledge of ophthalmology
Preferred: 5+ years experience of clinical trial, Knowledge of IOL and ophthalmology
English Level: Communication skills in English (TC with Belgium)
About interview
Liaison
CRA
RGF HR Agent
700 〜 1000 ten thousand JPY