- 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