Prolaio
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Artificial Intelligence • Big Data • Healthtech • Mobile • Wearables • Analytics
Serve as primary client contact for clinical research projects; lead internal teams to deliver projects on time and budget; onboard and train clients; identify growth opportunities; support contracting, pricing and budgets; generate performance reports; resolve operational issues and drive continuous improvement to grow accounts and ensure excellent client service.
Artificial Intelligence • Big Data • Healthtech • Mobile • Wearables • Analytics
Lead definition, roadmap, and validation of clinical endpoints for cardiovascular trials, including digital biomarkers, sensor and lab-based measures, and ePRO/eCOA. Select sensors/partners, define raw data capture, work with Data Science and Clinical on biomarker development, ensure regulatory and quality readiness (FDA/EMA, validation frameworks), and engage sponsors to prioritize and deliver trial-ready measures.
Artificial Intelligence • Big Data • Healthtech • Mobile • Wearables • Analytics
Support production quality activities including supplier qualification, in-process and finished goods inspections and release, environmental monitoring, complaint investigations, and transfer of products/processes from Design to Production. Report quality metrics to management and support regulatory compliance (ISO 13485, CFR Part 820).
