- Responsible for Project Management of PI-PIV of Regenerative Medicine Trials
- Work Anywhere in Japan
- Promising global bioventure with JNDA planned this summer.
- Specialized first in class regenerative therapy.
- Responsible for overseeing, supporting and supervising the CRO partner involved in management of the trials.
- Ensure adherence to established guidelines and standards, such as GCP regulations, resulting in a high quality output.
- Support data management activities required to report data obtained from previous trials.
- Close coordination with senior management and with other disciplines within the company to effectively manage all involved activities.
- Senior Additional responsibility for managing enquiries from PMDA and planning PMS studies.
- Working knowledge of ICH/JGCP guidelines and other regulations applicable to clinical project management
- Proven experience in clinical project management in a relevant organisation
- Demonstrated ability to manage late phase trials
- Experienced in working with a CRO, and being responsible for oversight, support and surveillance of the tasks assigned to the CRO
- Knowledge of data management procedures, and experience in supporting a data management vendor from cleaning study data, through database lock and final study report
- Self-motivated with ability to work independently with moderate supervision
- Organisation and experience working to deadlines
- Judgement and problem solving abilities to identify solutions to routine issues and seek guidance on more complex issues
- Strong interpersonal skills with ability to build consensus and work effectively in teams
- Current with relevant legislation and guidance
- Fluent Japanese, business level English
- Excellent attention to detail
- Excellent organisational skills with ability to manage priorities and work effectively and efficiently under pressure
- Knowledge and/or experience with cellular therapies preferred
- Opportunity to contribute to approval of new regenerative therapy in an area of unmet medical needs
- Contribute directly to the start-up activities of a global bioventure company in Japan
- Opportunity to work anywhere in Japan