Sr. Clinical Operations Lead
Core
Provide regional and global operational leadership across clinical trials, ensuring high-quality monitoring and site management throughout the study lifecycle.
Role type
Senior Clinical Operations Lead
Builds
Clinical trial programs for gastrointestinal disease treatments
Domain
Clinical Research / Pharmaceutical
Required skills
Clinical trial oversight, Monitoring plan development, Site management, Study start-up, Risk mitigation, Protocol compliance, CRA/COL mentoring, Regulatory knowledge (ICH-GCP), EDC systems
Preferred skills
10+ years clinical research experience, 2+ years in Clinical Operations Lead role
Technologies
EDC systems, Microsoft Office
Responsibilities
Provide regional/global clinical operations oversight ensuring compliance with protocols and regulations; Lead and mentor Clinical Operations Leads and Clinical Research Associates; Oversee monitoring deliverables including visit schedules, recruitment, and document collection; Lead country/site feasibility assessments and start-up activities; Coordinate between monitoring teams, project management, and Sponsors; Develop operational documentation and training materials; Review monitoring reports and performance metrics; Support budget oversight and resource planning.
Seniority
Senior, hands-on IC with leadership responsibilities
