Serve as the single point of scientific, administrative and regulatory control for the study
Participate and oversee all study activities (animal dosing, clinical signs observation, other relevant procedures, data collection, data analysis etc.,) in accordance with applicable regulations, OECD Principles of GLP and relevant SOPs
Operation, maintenance and usage of relevant equipment/instruments used (ex. centrifuge, laminar air flow, anesthetic machine, weighing balances, refrigerator, deep freezers, syringe pumps etc).
Preparation and revision of SOPs applicable to in vivo and in vitro experiments/procedures
Communicate critical information to key study personnel, the sponsor, and to responsible scientists as applicable
Authorize amendments and deviations to the study plan as applicable
Respond to QA findings and resolve them in a timely manner
Approval of study plan, amendments and study reports
Responsible for the timely archival of the study as per the current practices
All responsibilities as Study Director in accordance with the applicable SOPs

Technical knowledge, data analysis, reporting, hands on expertise

📌 Study Director General Toxicology Hyderabad
🏢 Aurigene Pharmaceutical Services
📍 Hyderabad