Narayan Sule

About Narayan Sule

Professionalism and strong work ethic.2. Critical thinking and Problem solving.3. Team work and collaboration.

Experience

1. Qc Reviewer

   Glenmark Pharmaceuticals

   Feb 2024 — Present · Mumbai, IN

   Job Responsibilities - • Monitored clinical phases of BA/BE and clinical trials ensuring compliance with ICH-GCP, SOPs, and local/global regulatory guidelines (e.g, USFDA, EMA, ROW) within defined timelines. • Review various submission reports (CSR) to regulatories Like USFDA, EMA, ROW market etc. • Conducted vendor audits to ensure adherence to quality standards and regulatory compliance. • Prepared comprehensive Clinical Monitoring Reports and conducted regular quality control reviews of study documentation. • Conducts quality control reviews in order to assure that documentation of Clinical projects are of the Highest standard and in Compliance with the Requirements of the SOPs, Study Protocols and Good Clinical Practice. • Reviewed volunteer data using NuLeAP software and ensured data accuracy across eMSR systems, CRFs, ICFs, screening consents, Study Master File & performed volunteer cross participation check by using OVIS Software. • Oversaw key study activities including screening, check-in, dosing, check-out, and routine safety monitoring. • Verified instrument calibration and validation reports for equipment used in clinical studies. • Assessed and documented protocol deviations/violations and ensured timely implementation of Corrective and Preventive Actions (CAPA). • Supervised end-to-end project activities, coordinating with cross-functional teams to ensure study completion within timelines. • Managed subject safety including AE/SAE monitoring, vital signs assessment, and clinical sample collection. • Oversaw sample processing (centrifugation, separation, storage) and ensured accurate sample dispatch to bioanalytical or external facilities. • Enforced adherence to Good Clinical Practice (GCP) and internal safety protocols across all study operations. • Completed additional responsibilities as assigned by the Head of Operations or Clinical Research Manager.

Education

• Mumbai University

  Masters of Pharmacy

  2024 — 2026

• Dr. Babasaheb Ambedkar Marathwada University, Aurangabad

  Bachelor of Pharmacy - BPharm

  2018 — 2022