Study Director: Responsible for the conduct of non-clinical safety (toxicology, safety pharmacology, toxico/pharmacokinetics) studies in animal.
• Reviews study schedules and prepares draft study plans and amendments for toxicity studies;
• Monitors the conduct of technical procedure performed in Toxicology Operations and Laboratories for safety studies;
• Coordinates study related activities where necessary with the section leaders;
• Instructs and monitors technicians in data generation procedures and technical work for their compliance with the study plan;
• master schedules and GLP requirements;
• Checks and/or prepares dose calculations for approval/signature by the SD;
• Reviews and signs raw data for accuracy and completeness within a specified interval and takes corrective action where appropriate;
• Liaises with sponsors and/or outside consultants on study-related matters;
• Participates in client visits relating to studies assigned to them;
• Be conversant, and function in compliance with guidelines and regulations published by governmental regulatory bodies (OECD, FDA, EPA and HPB). Participates in the review and revision of SOPs;
• Participates in Toxicology meetings;
• Assists in maintaining a safe working environment for himself/herself and his/her colleagues by observing all safety procedures and working methods;
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