Company Overview
Medical DevicesJob 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 ophthalmologyPreferred: 5+ years experience of clinical trial, Knowledge of IOL and ophthalmology
English Level: Communication skills in English (TC with Belgium)