Senior Manager, Clinical Management

Job description

Job Summary Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget. Job Description: o Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes. o Assuring compliance with departmental, SOP, compliance, and corporate training o Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities. o Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance. - Provides oversight and management of clinical studies at Otsuka, including planning, execution, and complet...