Akshay Hande

About Akshay Hande

4+ years of clinical research experience in diverse therapeutic areas, with a strong emphasis on Clinical Operations and TMF. Complete awareness of ICH/GCP guidelines, as well as a high regard for research integrity, protocols, and procedures. Experience and expertise of Trial Master File (TMF), Clinical Trial Management Systems (CTMS), VEEVA Vault, Medidata Rave, and Oracle. I am passionate about clinical trials because I believe that by working in this field, I can make a little contribution to research and the development of the world\'s health, which truly motivates me and provides me with both professional and personal satisfaction. I consider myself to be a thorough person, capable of prioritizing duties and working under pressure while remaining focused on producing high-quality results. Capable of managing complex projects and difficulties independently or as part of a team, and enthusiastic about working in the Clinical Research Industry. I enjoy dealing with individuals from all over the world, and I feel that communication is one of the most vital tools in both work and daily life.

Experience

1. Etmf Specialist Senior Associate (Clinical Operations)

   Atos

   Jul 2022 — Present · Pune, IN

   Working as an eTMF specialist for regulatory documents identification, categorization, and naming using the DIA Reference Model. eTMF Configuration, quality management, report\'s and metrics, TMF Quality Control (QC)/ Quality Assurance (QA) activities, and so on. To assist eTMF activites in overseeing the eTMF quality and integrity at a cross-functional level in order to meet regulatory requirements and inspection readiness at all times.

Education

• Savitribai Phule Pune University

  MS , Medicinal and Pharmaceutical Chemistry

  2016 — 2017

• The Bonn University Germany

  Associate's degree, Clinical Research