Drive clinical trial success at Puzzle Medical as a Clinical Operations Manager. Oversee studies from Early Feasibility to pivotal trials, ensuring compliance and quality management.

This full-time role requires managing clinical trials for Class II and III medical devices. You will be responsible for site management, monitoring, and ensuring inspection readiness, while leading the operational execution of studies. Your expertise in ICH-GCP and ISO 14155 will be crucial in optimizing trial timelines and managing CRAs and CROs.

Key Responsibilities:
• Lead clinical study operations from start to close-out
• Perform monitoring for EFS studies, including monitoring activities
• Build clinical operations infrastructure for pivotal trials
• Oversee site activation timelines and compliance
• Develop and maintain the electronic Trial Master File (eTMF)

Requirements:
• Bachelor’s degree required; advanced degree preferr...