Clinical Operations Professional with 13+ years of comprehensive experience in clinical research, regulatory compliance, and trial management across global Phase I-V studies.
Expert in managing regulatory documentation for 70+ clinical trials, Electronic Trial Master File (eTMF) systems, and CRO oversight in accordance with ICH GCP and FDA regulations. Proven expertise in site operations, protocol compliance, data management, and quality assurance with deep understanding of both sponsor-side operations and site coordination challenges. Skilled in Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and cross-functional team collaboration across multiple therapeutic areas.