Country Study Manager
Work for a Well-known European Pharmaceutical Company
Contibute to Development of Life-changing Medicines
- Major European pharmaceutical company with established portfolio and development pipeline in oncology, cardiovascular, infectious disease and other key therapeutic areas
- Conduct complex, global studies within the standards set by Global Development, according to Good Clinical Practices (ICH - GCP) and applicable regulatory and legal requirements.
- Management of investigator sites and site activities and monitoring of site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs.
- Ensure that Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out.
- Ensure overall patient safety related to reporting of serious or unexpected adverse drug reactions. Additional responsibility for training of Investigator and site staff on regulations and procedures for timely reporting and as well as monitoring ongoing compliance.
- Proactively identify potential issues and develop site Corrective Actions /Preventive Actions (CAPAs) Plans. The Study Manager / Country Lead Monitors ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
- University degree or above
- Extensive experience in the healthcare industry
- Monitoring & site management experience
- Responsible for site management and monitoring of applicable Phase I and all Phase II-IV complex and global clinical trials
- In-depth knowledge of the drug development process including monitoring and site management, local and international regulations, ICH - GCP, drug safety requirements, data management processes and investigator grant parameters
- Budget management experience
- Business Level English, fluent in Japanese
- Awareness and understanding of cultural/ regional operational differences
- Flexible work arrangements, competitive compensation, plus extensive additional benefits