[Hiring] Senior Clinical Study Manager @Viz.ai

Role Description

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 team.
  • Resolve issues, make decisions within your scope, and escalate appropriately.
  • Train and inform colleagues about study management and share best practices.

Qualifications

• 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).

Key Competencies

• Clinical study execution
• Project planning and timeline management
• Cross-functional collaboration
• Managing competing priorities
• Comfort operating in a fast-moving, pipeline-driven environment
• Commitment to quality and patient safety

Success Metrics

• Time from site selection to activation
• Number of sites activated against plan
• Enrollment against target
• Data quality and on-time, high-quality execution of assigned projects
• Documented improvement in the Viz clinical study management process within 90 days, evidenced by increased site activations and enrollments on industry and strategic partnership projects

Benefits

• Competitive cash compensation, equity, and benefits.
• Medical, dental, vision, 401(k), generous vacation, and additional benefits to full-time employees in the U.S.
• Comprehensive benefits package for employees in Israel, including dental insurance, performance-based bonuses, a Cibus meal allowance, meals at the office, and more.