CRA

Location: Japan - Tokyo
Job Type: Permanent
Salary: 7000000 - 10000000 JPY
Job Function: Clinical Development
Reference: JO-200514-217806
Industry: Life Sciences & Healthcare
Sub-Industry: Medical Devices

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)