Senior Clinical Study Manager

About Viz.ai

Viz.ai is the pioneer in the use of AI algorithms and machine learning to increase the speed of diagnosis and care, covering more than 200 million lives across 1,200+ hospitals and health systems in the U.S. and Europe. The AI-powered Viz Platform is an intelligent care coordination solution that identifies more patients with a particular disease, informs critical decisions at the point of care, and optimizes care pathways and helps improve outcomes. Backed by clinical data, the Viz Platform delivers significant value to patients, providers, and pharmaceutical and medical device companies. The company was named to the Forbes 2021 Next Billion-Dollar Startups list of the 25 fastest-growing venture-backed startups and has been on the Forbes AI 50 list for three consecutive years. For more information visit viz.ai.

The Role:

The Sr. Clinical Study Manager supports the efforts to plan, monitor, and execute clinical research trials. The Study Manager is specifically accountable for completing activities assigned to ensure appropriate sponsor oversight of sites in accordance with GCP guidelines, regulations, and project requirements. This role collaborates with personnel within the clinical department and across other functions at Viz and should be able to work proficiently by having a solid understanding of site-level activities and have a solid knowledge of the clinical research process. As Study Program Lead, you provide study management leadership to achieve the delivery of the study projects’ overall objectives to the Study Sponsors’ (or Strategic Clinical Partners) satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our Standard Operating Procedures (SOPs), policies and practices. The Study Manager will be given increased responsibilities in the Viz Clinical Affairs team to lead specific activities and can resolve issues, make decisions, and escalate issues appropriately. 

You will:

• 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” to meet our contractual requirements.
• Develop and maintain clinical project plans, including but not limited to Clinical Operations Plan, Regulatory Start Up Management Plan, etc. to be incorporated into the integrated study management plan/project management plan.
• Ensure accurate maintenance of internal systems (with emphasis on Clinical Trial Management System), databases, tracking tools, timelines, and project plans with project specific information.
• Organize clinical research studies to easily locate study documents and deliver status reports.

You will love this job if:

• You enjoy close collaboration across multiple teams. 
• Taking initiative to develop increased efficiency in the research process
• You are comfortable working with remote teams and are flexible with work schedules.
• You are keenly interested in the clinical study process and the factors that determine overall success of studies.
• You are passionate about delivering quality service, knowing that work in clinical research ultimately impacts patient safety.

 Requirements:

• At least 9+ yrs of clinical research experience in medical devices and/or SaaS sector required
• 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 the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback
• Knowledge of FDA regulations and Good Clinical Practices (GCP) preferred.
• Available to travel as needed (up to 30%) and ability to manage travel plans, such as flight schedules.

 What success looks like:

• You are determined to continuously improve your skills and work performance.
• You are making time to train and inform colleagues about study management.
• You take responsibility for your tasks and offer your support to the larger team as needed.
• You apply the Viz core values in your everyday conduct at work.
• You are managing competing priorities and ensuring on-time, high quality execution of clinical research projects
• After 90 days, there’s documented improvement in Viz Clinical Study Management process as evidenced by increased site activations and enrollments on industry & strategic partnership projects.

Viz offers competitive benefits, including medical, dental, vision, 401k, generous vacation, and other great benefits to full-time employees.  

Viz.ai is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics, or any other basis forbidden under federal, state, or local law. If you’re applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area.

As part of our commitment to health and safety, we require Viz.ai employees to be fully vaccinated before any in-person meetings unless you are exempt.

Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Salary Range: $120,000  - $155,000

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