Description

You will design and run IVX Health's clinical trials operating model, building a scalable site management platform and leading execution across multiple sites. You'll own regulatory compliance, quality, and SOP governance while serving as the senior external-facing executive for sponsors and CROs, ultimately assuming P&L ownership for the service line.

Requirements

• 10+ years senior experience in clinical trial site management or SMO leadership
• Direct hands-on leadership of clinical trial sites from start-up through close-out
• Deep expertise in FDA regulations, ICH GCP, IRB requirements, inspections, and audits
• Proven ability to lead cross-functional teams and serve as credible executive with sponsors and CROs
• Preferred: experience executing multi-site trials and exposure to P&L ownership

Responsibilities

• Build and operationalize a scalable clinical trial site management model
• Lead execution of clinical trials across multiple sites ensuring protocol adherence and quality
• Serve as senior accountable leader for regulatory compliance, SOP governance, and CAPA
• Partner with cross-functional teams to integrate research into clinical workflows
• Represent IVX Health as operational SME in sponsor and CRO discussions