kariusdx - Karius - Director, Clinical Operations

• Clinical Operations Strategy & Infrastructure • Design and implement a scalable clinical operations model to support multi-study, multi-site execution across OPTIMUM, AXIS, and future programs. • Establish standardized processes, tools, and playbooks for site start-up, monitoring, enrollment management, and study oversight. • Define and implement key performance indicators (KPIs) and dashboards to monitor study health (e.g., enrollment, data quality, protocol deviations, site performance). • Build and continuously improve systems to ensure consistent, inspection-ready execution across all studies. • Site Operations & Monitoring Excellence • Define and oversee the site management and monitoring strategy, ensuring appropriate resource allocation, monitoring models, and site engagement approaches. • Lead and develop the site operations function, including oversight of CRAs, contractors, and site-facing personnel. • Ensure consistent, high-quality monitoring practices and proactive issue identification and escalation across sites. • Partner with the Sr. Manager, Site Operations (or equivalent) to drive day-to-day execution excellence.