Description

You'll lead the end-to-end operational execution of Axogen-sponsored clinical trials, including randomized controlled trials, ensuring quality, compliance, and inspection readiness in highly regulated environments.

Requirements

• Bachelor's degree in scientific, medical, or engineering discipline
• Minimum 5 years of industry-sponsored clinical research experience
• Experience leading complex prospective interventional studies, RCT preferred
• Experience with biologics, combination products, and/or medical devices
• Willingness to travel up to 50%

Responsibilities

• Lead planning, start-up, execution, monitoring, and close-out of complex prospective clinical studies
• Serve as study operational owner accountable for timelines, quality, and compliance
• Develop and execute clinical operations, monitoring, and vendor oversight plans
• Ensure compliance with ICH-GCP, FDA, OUS regulations, and internal standards
• Lead vendor selection, onboarding, and performance oversight