Senseye Benefits Overview

Manage Senseye's virtual site for a Phase III SaMD trial from setup through closeout. Responsibilities include participant recruitment and visits, protocol compliance, regulatory submissions (IRB, consent, AE reporting), data quality assurance, training and supervising staff, timeline and budget management, cross-functional collaboration, and reporting clinical findings to stakeholders.

Lead clinical studies for SaMD products, oversee clinical operations team, manage external partners, ensure compliance, and support FDA submissions.

Owner of SaMD design-control and quality activities: implement and improve design inputs/outputs, traceability, verification/validation, risk management, and DHF readiness. Partner cross-functionally to apply IEC 62304/ISO 14971/ISO 13485 and FDA QMSR, support AI/ML model lifecycle quality, supplier controls, CAPA, and audit readiness.