Clinical Program Manager

Manage the full operational execution of clinical trials for Puzzle Medical Class II and III medical devices, with primary responsibility for site management, monitoring, and inspection readiness. Responsible for end-to-end delivery of studies from Early Feasibility Studies (EFS) through pivotal trials, including actual monitoring in early phases and scaling clinical operations through CRA and CRO management for later-stage studies. Ensures trials are executed on time, within budget, and in compliance with ICH-GCP, ISO 14155, and applicable regulatory requirements.

Responsabilities

• Lead operational execution of clinical studies from SQV through close-out, including site selection, activation, enrollment, and monitoring.
• Performs monitoring activities for EFS studies, including SQVs, SIVs, IMVs, and COVs, acting as the primary CRA. Oversee and optimize site activation timelines, including feasibility, contracts, budgets, and IRB/EC approvals.