Manager, Clinical Operations

About the role

The Manager of Clinical Operations will lead a high-performing team in overseeing, managing, planning, coordinating, and executing clinical projects. This role involves managing clinical execution plans, comprehensive clinical trial activities, and ensuring compliance with SOPs, GCP, and regulations.

Responsibilities

• Manage a high-performing clinical operations team by providing direction, subject matter expertise, training, and mentorship.
• Responsible for designing, developing, modifying, and evaluating clinical execution plans, including protocols, case report forms, consent forms, source document worksheets, budgets, timelines, gap analyses, etc.
• Accountable for comprehensive clinical trial activities such as study start-up, site activation, site management, vendor oversight, study reports, site and study close-out.
• Provide technical direction to CROs and oversee vendor selection/management as needed to execute clinical studies.
• Work closely with hospitals and investigators, maintain relationships with KOLs, other investigators, and site coordinators, and provide input and support for post-clinical activities and market launches.
• Establish and support cross-functional teams to ensure alignment of clinical, regulatory, commercial goals, site operations, data monitoring and review, and safety surveillance and reporting expectations.
• Ensure clinical research programs are conducted in accordance with company SOPs, GCP, and applicable regulations.

Requirements

• Bachelor’s degree in a scientific field or advanced degree with 8+ years of relevant clinical research experience in the medical device field.
• Proven success building and managing clinical operations teams.
• Comprehensive knowledge of clinical operations including GCP and all applicable US regulations.
• Experience with global clinical studies (e.g., EU or APAC regions).
• At least 2 years of monitoring experience.
• Experience with Class III medical device clinical studies.
• Effective verbal and written communication skills.
• Organized, self-motivated, able to manage multiple projects and priorities with high attention to detail.
• Strong team player with effective interfacing with other departments including translational medicine, regulatory, quality, product development.

Qualifications

• Bachelor’s degree in a scientific field or advanced degree with 5+ years of relevant clinical research experience in the medical device field.
• Proven success building and managing clinical operations teams.
• Comprehensive knowledge of clinical operations including GCP and all applicable US regulations.
• Experience with global clinical studies (e.g., EU or APAC regions).
• At least 2 years of monitoring experience.
• Experience with Class III medical device clinical studies.
• Effective verbal and written communication skills.
• Organized, self-motivated, able to manage multiple projects and priorities with high attention to detail.
• Strong team player with effective interfacing with other departments including translational medicine, regulatory, quality, product development.

Skills

• Experience with site and sponsor FDA BIMO inspections.
• Superior problem-solving skills.
• Experience with urology clinical studies.
• Effective interpersonal/communication skills.

Benefits

• Health & Wellness: Comprehensive health coverage, dental, and vision coverage.
• Work-Life Balance: Generous vacation pay, paid parental leave, options for flexible work schedules.
• Competitive Compensation: Annual bonus plan, long-term incentive plan (LTIP), 401(k) plan with employer match.
• Compensation Range: $145K - $200K.