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Study Director, Toxicology

The Study Director has the overall responsibility for the conduct of preclinical studies and is the single point of study control.

 

Responsibilities will include:

 

·Design, implement and interpret preclinical studies;

·Manage compliance and protocol activities, and ensure protocol is approved, distributed and followed ;

·Oversee the qualification of the study team;

·Monitor studies for assigned projects and assure studies are properly conducted;

·Resolve study-related problems in collaboration with internal departments;

·Monitor data collection and formulation, and review data promptly;

·Ensure the unexpected events are recorded accurately and corrective actions are taken to minimize the effect on the study;

·Preparing and auditing reports for regulatory submissions;

·Responsible for scientific contents of study reports;

·Ensure contents of reports accurately describe the studies;

·Responsible for prompt and effective communication with the sponsor.