Description
Lead clinical trials' operational execution as a Senior Clinical Operations Manager at Puzzle Medical. Manage site monitoring and trial delivery, ensuring adherence to stringent regulatory standards.
Puzzle Medical is looking for a Senior Clinical Operations Manager to spearhead clinical trial operations for their Class II and III medical devices. You will ensure studies are delivered on time, within budget, and compliant with ICH-GCP and ISO 14155. This role will involve strategic site management, extensive monitoring activities, and risk mitigation across trial phases.
Key Responsibilities:
• Manage full-cycle execution of clinical studies
• Monitor Early Feasibility Studies, providing CRA-level oversight
• Scale clinical operations and manage internal/external CRAs
• Optimize performance and oversee site activation processes
• Develop documentation standards for TMF processes
Requirements:
• Bachelor’s degree...
Puzzle Medical is looking for a Senior Clinical Operations Manager to spearhead clinical trial operations for their Class II and III medical devices. You will ensure studies are delivered on time, within budget, and compliant with ICH-GCP and ISO 14155. This role will involve strategic site management, extensive monitoring activities, and risk mitigation across trial phases.
Key Responsibilities:
• Manage full-cycle execution of clinical studies
• Monitor Early Feasibility Studies, providing CRA-level oversight
• Scale clinical operations and manage internal/external CRAs
• Optimize performance and oversee site activation processes
• Develop documentation standards for TMF processes
Requirements:
• Bachelor’s degree...
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