Vaibhav Dethe

About Vaibhav Dethe

With a solid foundation from Ajeenkya D Y Patil University, I\'ve honed my competencies in…

Experience

1. Clinical Research Associate

   Meril

   May 2025 — Present · Ahmedabad, IN

   As a Clinical Research Associate at Meril Life Sciences, I am involved in the execution and monitoring of clinical trials focused on innovative medical devices. My role ensures compliance with applicable regulatory guidelines, GCP, and ISO standards throughout the clinical investigation lifecycle.Key Responsibilities:•Monitor clinical trial sites to ensure compliance with protocol, GCP, and regulatory requirements•Assist in site initiation, interim monitoring, and close-out visits across multiple study centers•Collaborate with investigators and site staff to ensure smooth conduct of the trials•Review and verify clinical data for accuracy, completeness, and adherence to protocol•Maintain and manage essential documents using eTMF systems hosted on Amazon AWS•Support study start-up activities including ethics submissions, site feasibility, and contract tracking•Generate monitoring reports and track site progress using Meril EDC and related tools•Coordinate with cross-functional teams including data management, regulatory affairs, and clinical operations.Tools/Systems Used: • Meril EDC system • eTMF (hosted on Amazon AWS) • Microsoft Office Suite • Internal clinical trial management platformsSkills and Experience Gained:•End-to-end clinical trial monitoring in the medical device sector•Proficient in EDC systems and eTMF documentation•In-depth knowledge of GCP, ISO 14155, and local regulatory requirements•Strong communication and documentation skills.

Education

• Karmaveer Bhaurao Patil College - India

  12th

• Punyashlok Ahilyadevi Holkar Solapur University, Solapur

  Bachelor's degree

• Ajeenkya D Y Patil University

  Master's degree

  2021 — 2023

• Pune University

  SSC