Senior Manager, Global Site Start-Up Lead

Senior Manager leading global clinical trial site start-up activities for a biopharmaceutical company. The role involves developing start-up strategies, managing cross-functional teams, overseeing regulatory compliance, and partnering with clinical operations and CROs to accelerate study timelines and ensure operational excellence.

Responsibilities

• Develop and execute global site and country start-up strategies with risk identification and mitigation
• Lead site activation planning, forecasting, and milestone tracking to meet study timelines
• Partner with Clinical Operations, Regulatory Affairs, and CROs to drive efficient execution
• Monitor start-up metrics and use data to improve performance and inform decisions
• Manage and develop Site Start-Up team through coaching, performance management, and mentoring

Requirements

• Bachelor's degree and 8+ years pharmaceutical, biotech, or clinical research experience
• Extensive experience leading global clinical trial start-up and site activation activities
• Strong knowledge of ICH-GCP guidelines, clinical trial regulations, and global processes
• Demonstrated ability to lead cross-functional teams and influence stakeholders globally
• Proven experience managing vendors and CROs with performance oversight capabilities
• Direct line management experience with staff development and performance management