Senior Clinical Study Manager

About Viz. ai Viz. ai is the leader in building and deploying AI-powered Care Pathways and helping doctors do their work. The Viz Platform is deployed in 2,000 hospitals across the United States and trusted by many of the leading life sciences companies. The platform uniquely combines real-time, multimodal clinical data with deep clinician engagement to detect disease earlier, coordinate care teams, and help ensure patients receive the right treatment faster. Viz. ai was the first company to be awarded CMS reimbursement for AI and is ranked the #1 Healthcare AI Platform by hospitals and health systems in the Black Book Research survey. For more information, visit Viz. ai. Role Summary The Senior Clinical Study Manager plans, monitors, and executes the clinical research trials and pilots that demonstrate the real-world impact of Viz. ai 's AI-enabled care pathways, with a particular focus on Life Sciences partnerships and health system pilots. The role is accountable for sponsor oversight of sites in accordance with GCP, applicable regulations, and project requirements. As Study Clinical Study Manager, you provide study management leadership to deliver each study's objectives to the satisfaction of the Study Sponsor (or Strategic Clinical Partner) per contract, while optimizing speed, quality, and cost and following our Standard Operating Procedures (SOPs), policies, and practices. You will work closely with the Evidence Generation and Clinical team and with functions across Viz, resolve issues, make decisions, and escalate appropriately, and you will take on increasing responsibility to lead specific activities within the Evidence Generation team. Key Responsibilities Study Execution Oversee the execution of start-up, maintenance/operations, and close-out for assigned research projects in accordance with the Scope of Work and Project Plan.

Manage the operational aspects of projects to achieve quality data and efficient enrollment that meet contractual requirements. Complete assigned activities to ensure appropriate sponsor oversight of sites in accordance with GCP, regulations, and project requirements. Lead assigned study program activities, delivering to timeline, quality, and budget expectations. Planning and Systems Develop and maintain clinical project plans, including the Clinical Operations Plan and Regulatory Start-Up Management Plan, to be incorporated into the integrated study management plan/project management plan. Ensure accurate maintenance of internal systems (with emphasis on the Clinical Trial Management System), databases, tracking tools, timelines, and project plans with project-specific information. Organize study documents so they are easy to locate, and deliver status reports. Collaboration and Team Contribution Collaborate with Clinical and cross-functional partners (Product, Life Sciences, Legal, Finance) to keep studies on schedule. Maintain clear communication and provide status updates for the Resolve issues, make decisions within your scope, and escalate appropriately. Train and inform colleagues about study management and best practices. Qualifications and Experience Required At least 6 years of clinical research experience, preferably in the medical device and/or SaaS sector. Bachelor's degree in a scientific discipline or educational equivalent; other qualifications considered. Competent knowledge of clinical study project management practices and terminology. Proven ability to work through others to deliver results to quality and timeline metrics, including monitoring performance and providing feedback. Available to travel as needed (up to 30%) and able to manage travel plans. Preferred Knowledge of FDA regulations and Good Clinical Practice (GCP).