Clinical Research Associate - Med Device
Contribute to global clinical studies to support regulatory submissions and PMS
Contribute to the Development and Approval of Lifechanging Medical Devices
- Pioneering global medical device company with expertise in orthopedics, surgery, interventional solutions and vision care
- Assess study feasibility, contribute to study design elements, and collaborate with Clinical Strategy Lead and project team to develop protocols for clinical studies.
- Support training investigators, research coordinators, Contract Research Organizations (CROs), central laboratories, and other study vendors on study related procedures. Support providing first tier support for protocol, SOPs, and systems.
- With supervision, plan, manage, and report all aspects of global clinical studies through oversight of cross-functional study activities.
- With supervision, create and report clinical study updates to management on a regular basis; report on performance to plan.
- Coordinate and oversee clinical studies to support regulatory submissions
- Independently monitor, and / or assist CRAs with monitoring activities, to ensure compliance with study protocols, regulatory requirements, and company procedures.
- Follow current SOPs. May assist in the evaluation of current procedures for efficiencies and quality as well as make recommendations to management for improvements.
- Extensive experience in clinical development of medical devices
- Expertise in ICH, GCP and related regulations
- High level of communication skills
- Business level English (reading, writing, speaking)
- Fluent level of Japanese
- Opportunity to contribute to clinical development of medical device at a high level