K Starodubtseva
Medical writer
oct clinical trials
OCT Clinical Trials
Russian Federation
Biography
Ksenia has been working in OCT as a medical writer since February 2014 and started her career in clinical trials as a clinical research associate in a local CRO in 2012. After gaining experience in organization and conduct of clinical trials, Ksenia continued her development in scientific research and subsequently was promoted to the position of medical writer. In OCT Ksenia is responsible for writing all types of medical documents for regulatory submissions and development of clinical study design, sample size estimation, preparation of clinical study protocols, investigator’s brochures, subject information leaflets, clinical study reports as well as scientific articles for medical journals both in Russian and in English. While working as a medical writer, Ksenia acquired experience in a number of therapeutic fields including cardiology, neurology, endocrinology, rheumatology, oncology, and gynecology. As a medical writer Ksenia was involved in I-III phase studies, BE studies, and non-interventional observational programs. Her recent professional experience includes writing of documents and development of clinical trial designs for medical devices. Ksenia is a certified member of the European Medical Writers Association since 2014. She constantly improves her professional skills and knowledge through continuing education courses, various webinars and trainings. Ksenia graduated with honors from Altay State Medical University with MD degree and was a recipient of a scholarship from the Altay region administration during her three year study period. After completing her university studies, Ksenia had a one-year internship and a two-year residency in obstetrics and gynecology. She also worked as a gynecologist (fertility and reproduction management). Ksenia holds a bachelor’s degree in linguistics and intercultural communication and has medical translation experience.
Research Interest
clinical trials