Senior Clinical Study Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the initiation, ongoing operations, and closure of designated research projects.

• Manage project operations to ensure high-quality data collection and efficient enrollment in line with contractual obligations.

• Execute activities to ensure sponsor oversight of sites in compliance with GCP, regulations, and project specifications.

• Direct assigned study program activities within the established timeline, quality standards, and budgetary constraints.

• Create and uphold clinical project plans, including Clinical Operations and Regulatory Start-Up Management Plans.

• Sustain clinical trial management systems, databases, tracking tools, timelines, and project plans.

• Organize study documentation and provide status updates.

• Collaborate with Clinical teams and cross-functional partners in Product, Life Sciences, Legal, and Finance.

• Address issues, make decisions within the defined scope, and escalate matters as necessary.

• Educate and guide colleagues on study management and disseminate best practices.

• Enhance Viz clinical study management processes, site activations, and enrollment efforts.

⛳️ Requirements

• A minimum of 6 years of clinical research experience, ideally within the medical device and/or SaaS industry.

• Bachelor's degree in a scientific field or an equivalent educational background; other qualifications may be considered.

• Proficient understanding of clinical study project management practices and terminology.

• Demonstrated ability to lead others to achieve results that meet quality and timeline standards, including performance monitoring and feedback provision.

• Willingness to travel as necessary, up to 30%, and capable of managing travel arrangements.

• Familiarity with FDA regulations and Good Clinical Practice (GCP) is preferred.

• Authorization to work in the U.S. without requiring sponsorship, now or in the future.

🏝️ Benefits

• Equity

• Performance-based bonus

• Medical insurance

• Dental insurance

• Vision insurance

• 401(k)

• Generous vacation policy

• Flexible remote work options

• Mission-driven work culture

• Collaborative and innovation-focused team environment