Description

Lead and manage multiple complex clinical trials within one or more programs, acting as a central contact for Clinical Study Teams and partnering cross-functionally to ensure timelines and budgets are met. You'll drive risk management, vendor selection, and study documentation while supervising project status and problem-solving to meet goals.

Requirements

• Bachelor's or Master's in biological sciences or health-related field
• 10+ years direct Clinical Operations experience in pharma/biotech
• 6+ years cross-functional study management or leadership experience
• Strong knowledge of FDA Regulations, ICH Guidelines, and GCP
• Experience in CRO/vendor selection and management

Responsibilities

• Lead and manage all aspects of clinical trials within timelines and budgets
• Partner with cross-functional teams to manage project timelines and budgets
• Analyze data health metrics and share with stakeholders
• Conduct risk management, contingency, and scenario planning
• Participate in development of study-related documentation including protocols