Clinical and Medical Affairs Manager

The Clinical and Medical Affairs Manager will be responsible for ensuring compliance with regulations (SOPs, GCPs, FDA, Health Canada), managing clinical trials, and evaluating investigational sites in North America. Additionally, maintain the Trial Master File, collaborate with vendors for medical writing and data management, secure IRB approvals, and manage study budgets. The position also supports business development through relationship-building with clinicians and investigators and participates in medical affairs activities such as training sessions, continuing medical education events, and advisory boards.

• Ensure full compliance with all appropriate regulations: SOPs, GCPs, FDA, and Health Canada regulations.
• Assist in the planning, management, and execution of clinical trials.
• Help identify and evaluate investigational sites in North America.
• In collaboration with external vendors, assist in building, organizing, and maintaining the Trial Master File throughout the study.
• Collaborate with vendors for Medical Writing, Medical Monitoring, Data Management, and Statistics, as required.
• Help with planning and management of study budgets.
• Secure IRB study approvals and help with sites' IRB submissions and approvals.
• Support business development efforts by building and maintaining relationships with industry professionals, clinicians, and investigators.
• Collaborate and support North American medical affairs activities, such as training sessions, advisory boards, CME events, presentations, etc.
• Occasional travel may be required.