Priya Shetty

Sr. Centralized Monitoring Lead

• Job Details:Lead local study team(s) consisting of monitors and study administrator(s). Implemented strategic operational improvements that reduced study timelines by an average of 15%, thereby expediting drug development processes. Enhanced site compliance with protocol and regulatory requirements by 30% through rigorous training programs and quality control measures. Initiated cross-functional collaborations with lab services for precision medicine studies, aligning clinical objectives with patient-centric outcomes. Escalates issues or concerns regarding study activities to line management and the department leadership as needed. Managed study budget and resource allocation proactively, preventing cost overruns across concurrent trials.

Centralized Monitoring Lead

• Job Details:Successfully oversaw 100 site activations within 12 months, while ensuring compliance with GCP and ethical standards. Monitored clinical study sites, identifying and resolving issues, which enhanced data quality by 15%. Performed critical role in developing risk mitigation strategies that decreased audit findings by 40%. Managed eTMF documentation, achieving 95% completeness and accuracy ahead of FDA inspections. Fostered strong relationships with site personnel and internal team members, enhancing communications and study progress.

Centralized Monitor

• Job Details:Assisted monitors with onsite & remote visits and analyzed trends for risks. Performed remote monitoring visits. Implemented a revised patient follow-up system, improving data accuracy and reducing loss-to-follow-up rates by 10%.