? Supported the clinical research team by facilitating protocol approval process and maintaining documentation for all phases I/II & III of clinical Trials and regulatory submission like IND, NDA, CTA, etc.
? Helped manage new submissions, amendments, safety reports and review activities
? Collaborated with the clinical trial pharmacist to maintain processes and monitor practices to ensure complied regulatory documentation
? Assisted in maintaining proper documentation and compliance with the protocol
? Collaborated with various stakeholders and cross functional teams like clinical operations, development, and statistics to gather data, interpret and produce internal training and scientific publications.
? Perform clinical trial protocol analysis and review protocol flowcharts to confirm costing and payment strategies., Clinical Trials