Global Site Start-Up Lead

Overview

• Lead global site start-up activities for high-profile clinical trials, ensuring compliance with industry standards and guidelines.
• Collaborate with cross-functional teams and Clinical Research Organizations (CROs) to optimize site activation processes.
• Develop and implement site activation projections, mitigating risks and ensuring timely submissions.
• Monitor CRO performance through metrics analysis and implement corrective actions as needed.
• Ensure comprehensive documentation of site start-up materials in the Trial Master File (TMF).
• Provide strategic oversight and hands-on leadership to address challenges and achieve study objectives.
• Support regulatory submissions and ensure compliance with country-specific requirements.
• Drive process improvements and contribute to the development of the SSU team.

Key Responsibilities & Duties

• Develop site start-up strategies for assigned studies, addressing dependencies and mitigating risks.
• Monitor and analyze study metrics to evaluate CRO performance and ensure strategic objectives are met.
• Collaborate with cross-functional teams to align site activation projections and optimize site selection strategies.
• Lead all aspects of site start-up activities, including document collection, milestone tracking, and site initiation.
• Support regulatory submissions, including CIRB and LIRB processes, and ensure compliance with guidelines.
• Represent SSU in cross-functional teams, providing updates and resolving site start-up issues.
• Drive process improvements and recommend strategies for enhancing department efficiency.
• Manage SSU staff, providing coaching, mentoring, and professional development opportunities.

Job Requirements

• Bachelor of Science (BS) degree required; advanced degree preferred.
• Minimum of 5 years of experience in global site start-up activities; 8 years preferred.
• Proven expertise in clinical trial site activation and regulatory submission processes.
• Strong knowledge of ICH-GCP guidelines and industry standards.
• Experience in managing cross-functional teams and collaborating with CROs.
• Excellent analytical skills for monitoring metrics and implementing corrective actions.
• Proficiency in maintaining Trial Master File (TMF) documentation and ensuring inspection readiness.
• Strong leadership and communication skills to manage teams and resolve issues effectively.