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I’m responsible for overall planning, execution, monitoring, and closure of assigned clinical trials—ensuring studies run in compliance with ICH-GCP, regulatory requirements, sponsor expectations, and company SOPs. I deliver projects on time, within budget, and with required quality standards while safeguarding subject safety and data integrity throughout the study lifecycle.

In my current role as PROJECT MANAGER, I manage 8+ multi-center Oncology phase studies and Patient PK studies across India, covering the full lifecycle from CT-01 submission through study close-out. I oversee studies with 30–100+ subjects per trial and maintain zero critical GCP findings during internal and regulatory inspections.

I improve execution quality through risk-based monitoring and preventive tracking—reducing protocol deviations by 25% using risk-based monitoring plans, early site engagement, and deviation tracking dashboards. I also coordinate cross-functional teams of 10–20+ stakeholders (Medical, PV, Regulatory, CRA, DM, and Biostatistics) to maintain milestone adherence under tight recruitment timelines.

I’m proactive during enrollment and start-up challenges, implementing structured timeline recovery strategies that recover up to 20% schedule slippage. I manage clinical trial budgets up to ₹25 Crore (cost variance within ±5%), ensure 100% CTRI registration compliance prior to FPI, keep the TMF inspection-readyTMF throughout, and lead end-to-end start-up activities including feasibility, site selection, regulatory submissions, ethics approvals, and Site Initiation Visits (SIV).