French

• Responsible for country-level quality deliverables and compliance with project requirements and applicable country rules
• Track submission and approval milestones in the SSU tracking system and investigate or escalate timeline delays
• Monitor basic project financial aspects and contracted hours/tasks
• Review and comply with SOPs and Work Instructions and maintain training records and timesheet compliance
• Support quality improvement across Site Start-Up components, including submissions, essential document collection, and communication with Competent Authorities and Ethics Committees
• Ensure relevant documents are submitted to the Trial Master File
• Prepare and submit Central and Local Ethics Committee applications, Regulatory Authority applications, and other local regulatory or hospital approval submissions
• Prepare ongoing submissions, amendments, periodic notifications, and safety notifications as required
• Liaise between investigational sites and functional leads and oversee the end-to-end site activation process
• Provide country-level regulatory intelligence and support data protection guidance
• Provide input to local SOPs, Work Instructions, and internal training materials
• Support Ethics Committee or Competent Authority issue resolution
• Support site selection and feasibility activities
• May support investigator contract and budget negotiation, contract preparation, quality control, execution, archival, and metadata capture

French jobs in Canada

Site Activation Specialist, French Speaker