Serve as the operational Study Lead for a global pivotal Phase 3 study (North America, South America, Africa, and Europe), maintaining responsibility for successful execution from protocol development and start-up through enrollment, database lock, study closeout, submission support, and inspection readiness. Maintain a continuous state of inspection readiness across the study, including safety reporting, TMF completeness and quality, essential documentation, evidence of vendor oversight, issue and CAPA management, and audit preparedness, in close partnership with Quality Assurance (QA).