Jaya Krishna Rayaroth

Professional with 10+ years’ experience in Clinical Domain which include Sponsor and Investigator Site such as Meishi Pharma (Lotus Pharma), Orbicular, Zydus Cadila, Unichem Labs, Quest life Science. Project Management in Clinical Development: Strategic planning, Study design, Study feasibility, Site selection, Vendor & Budget management, Coordination, and Execution of the Clinical & Nonclinical studies across the globe and support for marketing Authorization. Hand on experience in 505 B2 Application, Hybrid Application, first to file project, Complex Molecule projects, BCS Biowaiver Permeability study. Developed project plans and led a large cross functional operations team to execute projects Medical Writing: Clinical and Nonclinical Overview, CDISC dataset, Review of eCTD dossier. Audit & Monitoring: CRO Pre-qualification and Monitoring of more than 150 BE studies at different sites and ensure compliance with Protocol, ICH-GCP and applicable regulatory requirements. Sponsor Over sites visit experience of Phase III Study & Non-Clinical study. eCTD Software Experience: EDUCE Critical thinking | Troubleshooting | Excellent teamwork and expertise in maintaining effect. Scientific justifications to regulatory for study designs. Resourceful Project Manager with 10 + years of expertise in organizing business operations, financial oversight and resource management to achieve smooth flow and project operations. Leads procurement of resources including equipment and supplies. Monitors projects by adhering to production schedule and budget, managing production team, identifying problems and providing targeted solutions. Knowledgeable in accounting principles, bookkeeping, budget, and financial management.

• Father's Name: Rayaroth Ashok
• Date of Birth: 08/20/1989
• Nationality: Indian
• Marital Status: Married