GCT is happy to announce a new hire in the Slovak office – Olena Datsenko, MD, Ph.D., who is taking on the position of Medical Safety Associate.
Olena brings to GCT more than 20 years of experience working as a Principal Investigator in Kharkiv, Ukraine. She conducted more than 120 clinical trials in various fields, including coloproctology, surgery, and oncology. During this time, she successfully passed more than 60 independent and sponsor audits.
“Olena will be a great addition and support to our pharmacovigilance team. She has a solid academic background, with over 15 years of medical practice and extensive knowledge of the safety requirements in clinical trials, both from the perspective of the research center and the sponsor. Welcome to the team, Olena!”
Daria Podgorska, M.D., Ph.D., MBA, General Director
Being a renowned physician and PI, Olena has provided an expert review of clinical trial protocols: overall protocol design, objectives, and endpoints, inclusion and exclusion criteria, concomitant treatment, study assessments, and procedures. She has performed full assessments of study protocol compliance with guidelines, manuals, regulations, operational procedures, and SOPs, evaluating findings, and delivering recommendations for the best possible structure of the trial.
Having worked with various pharmaceutical companies, she has also gained a lot of experience with multiple eCRFs, site file maintenance, and GCP/GVP compliance.
Dr. Datsenko demonstrated excellence in proactive safety surveillance and risk management for many assigned clinical studies. She independently evaluated data to identify potential safety signals, resolved hard clinical cases in multiple indications (inflammatory bowel diseases, surgical diseases, gastroenterological diseases, oncological diseases), and evaluated risks related to patient safety. She has been collaborating with clinical safety scientists to develop materials (presentations, safety analyses/evaluations, etc.) as well as organizing product-level safety meetings and medical scientific conferences.
Welcome to the team, Olena!