Senior Clinical Study Manager
About The Position
The Senior Clinical Study Manager plans, monitors, and executes clinical research trials and pilots demonstrating the real-world impact of Viz.ai’s AI-enabled care pathways, with a focus on Life Sciences partnerships and health system pilots. The role provides sponsor oversight of sites in accordance with GCP, applicable regulations, and project requirements, and leads study management to meet objectives and sponsor or strategic clinical partner expectations under contract while optimizing speed, quality, and cost and following company SOPs, policies, and practices. The position works closely with the Evidence Generation and Clinical teams and cross-functional partners across Viz.ai to resolve issues, make decisions, and escalate appropriately. It also takes on increasing responsibility for leading activities within the Evidence Generation team. The role is remote-first across the U.S. and EU; Viz.ai’s team in Tel Aviv operates in a flexible hybrid model. Travel may be required, up to 30%.
Requirements
- 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 may be considered.
- Competent knowledge of clinical study project management practices and terminology.
- Proven ability to work through others to deliver results against quality and timeline metrics, including monitoring performance and providing feedback.
- Availability to travel as needed, up to 30%, and ability to manage travel plans.
Nice To Haves
- Knowledge of FDA regulations and Good Clinical Practice (GCP).
Responsibilities
- Oversee start-up, maintenance/operations, and close-out for assigned research projects according to the Scope of Work and Project Plan.
- Manage project operations to achieve quality data and efficient enrollment in line with contractual requirements.
- Complete assigned activities to ensure sponsor oversight of sites in accordance with GCP, regulations, and project requirements.
- Lead assigned study program activities to meet timeline, quality, and budget expectations.
- Develop and maintain clinical project plans, including the Clinical Operations Plan and Regulatory Start-Up Management Plan, for inclusion in integrated study management or project management plans.
- Maintain accurate project-specific information in internal systems, particularly the Clinical Trial Management System, as well as databases, tracking tools, timelines, and project plans.
- Organize study documents for easy retrieval and deliver status reports.
- Collaborate with Clinical and cross-functional partners, including Product, Life Sciences, Legal, and Finance, to keep studies on schedule.
- Communicate clearly and provide status updates.
- Resolve issues, make decisions within the role’s scope, and escalate appropriately.
- Train and inform colleagues about study management and share best practices.
- Manage travel plans as needed.
Benefits
- Competitive cash compensation and equity.
- Medical, dental, and vision benefits for U.S. employees.
- 401(k) for U.S. employees.
- Generous vacation for U.S. employees.
- Additional benefits for full-time U.S. employees.
- For employees in Israel: dental insurance, performance-based bonuses, a Cibus meal allowance, and meals at the office.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
