Clinical Research and Clinical Operations professional with 8+ years of progressive experience across global CROs supporting Phase III vaccine, oncology, ophthalmology, immunology, hematology, and observational studies. Experienced in site management, regulatory start-up, contract and budget negotiation, TMF oversight, and cross-functional collaboration with global sponsors and investigative sites. Proven ability to manage multiple trials simultaneously while ensuring compliance with ICH-GCP, FDA, and local regulatory requirements.