Senior Manager, Clinical Field Operations

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
The Opportunity That Awaits You:
The Senior Clinical Field Operations Manager oversees the planning, execution, and management of clinical studies for all site management related activities. This role requires a seasoned professional with extensive experience in clinical field operations, strong leadership skills, and a deep understanding of regulatory requirements. It also requires the individual to have a proven track record in managing multi-site clinical trials, and the ability to lead and mentor field teams. The Senior Manager will lead a team of clinical research professionals to ensure that clinical studies are conducted efficiently, on time, and in compliance with industry standards. This role reports into the Senior Director of Clinical Affairs.

What Your Day-To-Day Will Involve:

•         Clinical Operations Management:
Lead the coordination and management of clinical trial operations across multiple sites, ensuring compliance with Good Clinical Practice (GCP), FDA regulations, and other relevant regulations and guidelines where the clinical studies are being conducted.Oversee the selection, training, and ongoing management of clinical sites, including investigators and site staff.Monitor site performance, patient recruitment, and study timelines to ensure that project goals are met within budget.Provide leadership and direction to the Clinical Research Associates (CRAs), and other field operations personnel.May serve as the primary point of contact for clinical sites, ensuring effective communication and issue resolution.
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•    Regulatory Compliance and Quality Assurance:
Ensure all clinical operations adhere to regulatory requirements, company SOPs, and industry best practices.Support the preparation and submission of clinical trial documentation, including protocols, informed consent forms, and other regulatory submissions.Assist with regulatory audits and inspections, providing necessary documentation and support.
•          Data Management and Reporting:
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, highlighting key metrics, challenges, and outcomes.Contribute to the development and review of clinical study reports and publications. Process Improvement and Innovation: Identify opportunities to enhance the efficiency and effectiveness of clinical field operations.Stay informed of industry trends, technological advancements, and regulatory changes that may impact clinical operations.Develop and implement process improvements and best practices to optimize clinical trial execution.

The Qualifications We Need You to Possess

• 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, with a 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 global clinical operations is highly desirable.
• Must have experience with FDA BIMO audit at the study level and the site level.
• Must have experience with eTMF and EDC system utilizations.

The Qualifications We Would Like You to Possess

• CCRA, CCRP, or SoCRA certification preferred.
• Global research experience preferred.
• Domestic and international travel would be required for site training, monitoring responsibilities, and educational seminars. Ability to travel up to 70%.

For US-Based Candidates OnlyWork Authorization Status: Citizen / Permanent Resident For this role, the anticipated base pay range is $125,000- $173,000 per year.Plus, eligibility for an annual bonus and equity/RSUs.
Understanding PROCEPT's CultureAt PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with