Avanir Pharmaceuticals
Aliso Viejo, CA, USA
Under the supervision of the Director of Clinical Research, the Senior Clinical Study Manager is responsible for the oversight and management of Avanir clinical studies, including coordination with other relevant parties (e.g., other Avanir departments, contract vendors, etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Avanir SOPs, within agreed-upon timeframes and budget. Essential Job Functions: Provides oversight and project management of clinical studies at Avanir, including planning, execution, and completion of clinical trials according all applicable regulations and guidance, ICH/GCP, and Avanir SOPs. Manage and facilitate development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Study Plans, Case Report Forms, Source Documents,...
