Chowdary

Background

About Chowdary

I am an accomplished Clinical Research Professional with over 8 years of experience in end-to-end clinical trial operations, spanning Phase I–IV, BA/BE, and PMS studies across oncology, immunology, and other therapeutic areas. I bring strategic oversight and hands-on expertise in site management, regulatory compliance, monitoring, and cross-functional collaboration, ensuring the success of high-quality, GCP-compliant trials. Currently, I serve as a Clinical Trial Manager at Ardent Clinical Research Services, where I lead and oversee comprehensive clinical operations—study planning, site feasibility, regulatory submissions, team coordination, vendor management, and monitoring oversight. I ensure timelines, budgets, and protocol adherence while collaborating with investigators, sponsors, and stakeholders to deliver robust clinical outcomes. Previously, as Senior Clinical Research Associate at Ardent and Site Manager – Clinical Operations at SIRO Clinpharm Pvt. Ltd, I managed trials involving Monoclonal Antibodies (Doclizumab, Adalimumab, Italizumab), oncology drugs (Cabazitaxel, Imatinib, Capecitabine), and PMS trials (Cisplatin, Diclofenac, Lidocaine). I was involved in site feasibility, selection, initiation, vendor qualification audits, and mentoring co-monitors. At Jeevan Scientific Technology Ltd, I ensured regulatory-compliant trial conduct, from site qualification to closeout. I supported protocol compliance, patient follow-up, data collection, CRF handling, query resolution, and monitored subject safety as per ICH-GCP and NDCT Rules 2019. My journey began as a Clinical Research Coordinator at GVN Institute of Oncology, where I screened patients, scheduled follow-ups, managed trial documentation, and performed data entry and reconciliation—all within oncology-focused protocols. Core Skills: Clinical Trial Management | Oncology & MAb Trials | Site Monitoring | Regulatory Submissions | Vendor Qualification | ICH-GCP | NDCT Rules | PMS Studies | Protocol Compliance | CRA Training | Data Management | MedDRA/WHO-UMC | MS Excel & CTMS/EDC I’m committed to advancing ethical, patient-centric research that drives innovation and impacts lives. Let’s connect if you are interested in collaboration or building clinical research excellence.