Draft study protocol, amendment, data summary and study report for submission to Study Director, oversee submission to internal review and ensure updates with revisions are accurate and complete
Initiate and update study activity scheduling requests, and coordinate study needs with operational areas independently
Maintain familiarity with routine study procedures, monitor phases of a study and reports issues to Study Director, identify opportunities for process improvement and assist in issue resolution
Exposure to animals for study monitoring (this may also include minimal exposure to formalin, test article/dosing formulations, blood and/or tissue samples)
Coordinate with formulation, animal pathology operation, and clinical pathology
Timely communication with client on study activities and study management
Review data packages from the lab areas and ensure the compliance with data integrity and good research practice, ensure the timely archive of study documents
Leadership in the development of new technical capabilities and disease models for discovery services and assist with the training of the technical personnel
Organize and participate in pre-study and other study-related meetings including client visit as required
Education/Qualifications:
Master in pharmacology or relevant and equivalent degree
Experience:
- At least 3 or more years of relevant drug discovery experience in a pharmaceutical or biotechnology company setting
- In vivo model hands-on experience required
- Research and model development experience in Diabetes and Metabolic Disease, hepatitis, NASH, and liver fibrosis preferred
- Experience in study conduct in a matrix resource environment preferred
Location: 上海浦东新区康新公路3377号
职能类别: 生物工程/生物制药
联系方式
上班地址:周浦康新公路3377号
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