Leads preparation for monitoring and audits, develops operational processes and tools, supports complex study visits and participant screening, facilitates cross-functional collaboration, and mentors staff to ensure high-quality research operations, effective communication, and achievement of study goals. Serves as a senior research operations and regulatory expert across multiple study teams, providing oversight, training, and strategic guidance on regulatory compliance, institutional policies, investigational product management, participant recruitment and retention, study documentation, specimen management, SOP development, and study conduct.