Clinical Trial Manager - APAC Level
Tokyo 23 Wards
Permanent
¥11,000,000 - ¥13,000,000
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Expanding US Bioventure with Breakthrough Therapy in Rare Disease Area
Lead APAC Level Studies at a Project Level
About Our Client
- US Headquartered Bio-pharmaceutical company with approved product in the immunological rare disease area.
- Expanding development pipeline in US as well globally
Job Description
- Provide regional Clinical Operations management across 1-2 key trials in the APAC region in compliance with GCP and all related regulatory frameworks
- Manage vendor adherance to protocol, regulations and measure and oversee key study metrics to ensure projects are running smoothly and that all deliverables are being met in a timeline and effective manner
- Actively participate in investigator meetings, kick-off meetings, monitoring training and various CRO meetings
- Provide updates to management on study progress, and approve acctionacction plans in order to resolve issues relating to quality, safety, data and administrative matters on the part of CROs
The Successful Applicant
- University degree, preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred
- Extensive experience in clinical operatoins within the global pharmaceutical or CRO industry
- Good experience of clinical development / drug development process in various phases of development and therapy areas.
- Knowledge of process improvement methodology
- Evidence of developing partnering skills
- Native level Japanese
- Business level English
What's on Offer
- Contribute to expansion of a promising global bio-pharmaceutical company in Japan
- Opportunity to work on APAC level projects
- Opportunity to move from CRO into a pharmaceutical company