Amit Paudel

About Amit Paudel

Senior Medical Writer with 7+ years of progressive experience in imaging-driven clinical trials, spanning imaging operations, scientific review, and medical writing within global CRO environments.Currently working as Senior Medical Writer at Imaging Endpoints, supporting imaging studies across clinical trials by delivering high-quality medical and scientific documentation in line with project scope, regulatory expectations, and sponsor timelines. My role includes authoring and reviewing key imaging documents such as Independent Review Charters, Imaging Manuals, eCRF components, and assessment criteria guidelines, while ensuring data quality and traceability through close collaboration with Data Management and Medical Application Services teams like Mint.Previously held progressive scientific roles at Perceptive (formerly Calyx, Parexel), advancing from Imaging Research Associate to Senior Scientist. In these roles, I provided scientific guidance for eCRF design, imaging workflow configuration, and customization of image analysis platforms, and acted as a liaison between radiologists, oncologists, sites, and internal project teams. I was responsible for medical quality monitoring, reviewer performance oversight, query management, and training of independent reviewers and sites on imaging parameters and assessment criteria.My background includes hands-on experience across Phase clinical trials in multiple therapeutic areas including oncology, dermatology, rheumatology, and metabolic bone disease, with exposure to CT, MRI, PET, X-ray, bone scans, and photographic imaging modalities. I bring working knowledge of image processing, Base SAS, and data review workflows to support quality control, listings, and medical review activities.I am particularly strong in roles that sit at the intersection of imaging science, clinical data quality, and medical writing, where scientific accuracy, consistency, and regulatory compliance are critical.

Experience

1. Senior Medical Writer

   Imaging Endpoints

   Apr 2024 — Present · Hyderabad, IN

   Provide written Medical/ Scientific input into Study protocols, Clinical case Report forms, Imaging component of regulatory submissions and Assessment criteria guidelines. And also, to support training to Radiologist, Oncologist and other sub-specialty physicians on Project specific Image review charter/reader rules, Image analysis platform and Protocol specific assessment criteria.

Education

• Kendriya Vidyalaya

  Intermediate, Maths, Biology, Physics and Chemistry (M.Bi.P.C)

  2009 — 2011

• Hindu Public School

  CBSE

  2002 — 2009

• Malla Reddy College of Pharmacy (MRCP), Secunderabad

  Graduation, Pharmacy

  2012 — 2016