|職名||Clinical Study Manager|
|勤務地||Japan - Tokyo|
- Oversee the delivery to plan of studies performed by external partners (CROs, vendors and Site) and monitoring progress by identifying risk and solve operational issues.
- Lead and manage all activities related to site management and monitoring with agreed timelines, budget and company standard quality.
- Plan and deliver site selection/ patient recruitment strategy
- Ensure the quality of clinical study data by raising queries and deviation and resolve issues in a timely manner.
- Develop and manage risk mitigation plans and contingency plans to execute CRO/site management
- University degree (or equivalent), preferably in medical or biological sciences or discipline associate with clinical research. Advance degree is preferred
- At least 6 years experiences from within the pharmaceutical industry or similar organization or academia experience
- Good experience of clinical development/drug development process in various phases of development and therapy areas
- Extensive knowledge of clinical operations, project management tools and processes