PROCEPT BioRobotics is hiring a
Senior Manager Clinical Field Operations

Summary

The Senior Clinical Field Operations Manager role at PROCEPT BioRobotics involves overseeing clinical studies for all site management activities. The position requires extensive experience in clinical field operations, strong leadership skills, and knowledge of GCP, FDA regulations, and other relevant guidelines. The job involves coordinating and managing clinical trial operations across multiple sites, ensuring compliance with regulations, data management, process improvement, and innovation. The role is a US-based position with an anticipated base pay range of $125,000-$173,000 per year, plus eligibility for an annual bonus and equity/RSUs.

Requirements

• Bachelor’s degree in life sciences, nursing, or a related field. Advanced degree preferred, or equivalent combination of education and experience
• At least 7-10 years of experience in clinical trial management within the medical device industry
• Minimum of 3-5 years in a leadership or senior management role
• Extensive knowledge of GCP, FDA regulations, and other relevant clinical and regulatory guidelines
• Experience with FDA BIMO audit at the study level and the site level
• Experience with eTMF and EDC system utilizations

Responsibilities

• Lead the coordination and management of clinical trial operations across multiple sites
• Ensure compliance with Good Clinical Practice (GCP), FDA regulations, and other relevant regulations and guidelines
• Oversee the selection, training, and ongoing management of clinical sites
• Monitor site performance, patient recruitment, and study timelines
• Provide leadership and direction to the Clinical Research Associates (CRAs), and other field operations personnel
• Serve as the primary point of contact for clinical sites, ensuring effective communication and issue resolution
• Oversee the accurate and timely collection, management, and analysis of clinical trial data
• Provide regular updates and detailed reports to senior management on the status of clinical operations
• Contribute to the development and review of clinical study reports and publications
• Identify opportunities to enhance the efficiency and effectiveness of clinical field operations

Preferred Qualifications

• CCRA, CCRP, or SoCRA certification
• Global research experience

Benefits

• Full medical coverage
• Wellness programs
• On-site gym
• 401(k) plan with employer match
• Short-term and long-term disability coverage
• Basic life insurance
• Wellbeing benefits
• Flexible or paid time off
• Paid parental leave
• Paid holidays