Become a Clinical Trials Manager at Puzzle Medical, focusing on the operational execution of clinical studies. Excel in site management and regulatory compliance for innovative medical devices.
Puzzle Medical is hiring a Clinical Trials Manager who will oversee the operational aspects of clinical trials for Class II and III devices. Your role will cover all stages from feasibility to pivotal trials, ensuring alignment with regulatory requirements like ICH-GCP and ISO 14155. Lead CRA teams and implement risk-based monitoring for quality assurance.
Key Responsibilities:
• Oversee clinical studies from initiation through close-out
• Perform direct monitoring for feasibility and pivotal studies
• Build infrastructure for clinical operations, managing CRAs
• Ensure adherence to study timelines and compliance metrics
• Lead audits and inspections for TMF integrity
Requirements:
• Bachelor’s degree; advanced preferred
• 10+ years in clinical operations in medical...