Olena Datsenko Email and Phone Number
Strong reputation for opening and running clinical sites. Ensure that all interactions and engagements carried out with the highest ethical and professional standards and that all work accomplished with quality and in line with sponsor values. Highlights & Key Profile Offerings: ✔ Select sites conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations.✔ Steer scientific execution of global clinical studies, savvy in translating findings into clinical development opportunities and advising on future design of studies.✔ Demonstrated excellence in supporting proactive safety surveillance and risk management for assigned clinical studies and independently evaluating safety data to identify potential safety signals. ✔ Ensure valid study outcomes and reduce health disparities by purposefully recruiting, enrolling, and retaining diverse and, at times, untrusting participant populations. Instrumental in collaborating with clinical safety scientists to develop materials (presentation, safety analyses/evaluation, etc.) for product-level safety meetings. ✔ Diagnosed and resolved hard clinical cases, including inflammatory bowel diseases, surgical diseases, gastroenterological diseases, oncological diseases for several studies. ✔ Extensive experience in reviewing of the CT Protocols (overall protocol design, objectives and endpoints, inclusion and exclusion criteria, concomitant treatment, study assessments and procedures) on Sponsor’s request. ✔ Delivered full assessment compliance with all parts of the protocol; compliance study protocol with study guidelines, manuals, regulations, operation procedures, and SOPs. ✔ Evaluated all findings and distributed reports, recommended best possible structure of the trials, and organized the work to ensure successful and effective clinical trials. ✔ Foster and retain effective intra-personal working communication with coworkers, CRO, and study team; efficiently organize medical scientific conferences and meetings.
Global Clinical Trials (Gct)
View- Website:
- gctrials.com
- Employees:
- 50
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Medical Safety Specialist, Md PhdGlobal Clinical Trials (Gct) Jan 2023 - PresentBratislava, Slovakia -
Principal Investigator"Kharkiv City Clinical Hospital #2 Named After Prof. O.O. Shalimov" May 2016 - May 2024Kharkiv, UkraineIn this role, I am accountable for spearheading end-to-end management and organization of global work of investigator site along with full responsibility as a PI according GCP. Direct full spectrum control of the metrological conformity of the quality of equipment used in the CT. Track the compliance of the premises (offices of investigators, storage rooms for the study drug, equipment, and materials provided by the sponsor for conducting CT, departments, and offices of the hospital, the separate archive for long-term storage of CT materials after completion of the study) with the requirements for conducting CT. Select and train staff participating in the CT as well as attract patients to CT (communication with doctors from other hospitals, hospital database analysis, establish and maintain patient referral network).Highlights of my accomplishments: ➺ Total in CT practice: 121 studies provided successfully. 62 both sponsor and independent audits passed successfully, with no major or critical findings (total in CT practice).➺ Worked with following customers/sponsors: AstraZeneca, Celgene Corporation, Dr. Falk Pharma GmbH, Eli Lilly, Gilead Science, Janssen Research & Development, Pfizer, Roche, Takeda Pharmaceutical.➺ Enabled the site to become one of the best in Ukraine and as the prime site of many CROs.➺ Strategized and executed scheduled visits of patients, monitoring the general condition of patients, the results of laboratory and instrumental examinations, registration of AE, and reporting of SAE.➺ Controlled and verified eCRF data, engaged in site file maintenance, filled out questionnaires including feasibility questionary, and interfaced with LEC, CRO, medical adviser, project team, and sponsor.
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Resident Of The Proctology Department, Coloproctologist, Doctor Of The Highest Category“City Clinical Hospital #2 Named After Prof. O.O. Shalimov", Department Of Proctology Jul 2006 - May 2024Kharkiv, UkraineDuring this tenure, I delivered all types of coloproctological procedures, manipulations, and operations; patients counseling and treatment; and rectoscopy and sigmoidoscopy.Key success: ➺ Actively engaged in medical practice, consultations, diagnostics, and treatment of patients.
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Sub-Investigator“Kharkiv City Clinical Hospital #2 Named After Prof. O.O. Shalimov” Sep 2001 - May 2016Kharkiv, UkraineAt this organization, I attained a strong understating of the features of each role of the staff along with the mechanisms and ways of attracting and retaining patients in CT. Organized, built, and maintained communication of the center with external vendors, representatives of the central laboratory, the central team, medical advisers, and sponsors. My notable contributions: ➺ Examined and identified the causes of inefficient work of the staff, provided recommendations for improving the quality of work.➺ Acquired extensive experience in performing various tasks in СT, developing a strategy to draw up an algorithm for the effective implementation of any task.
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Resident Of The Sugical Department, General Surgeon“Kharkiv City Clinical Hospital #2 Named After Prof. O.O. Shalimov”, Surgery Department Mar 2001 - Jul 2006Kharkiv, UkraineDuring this tenure, I delivered all types of general surgery procedures, manipulations, and operations; patients counseling and treatment; and rectoscopy and sigmoidoscopy.Key success: ➺ Actively engaged in medical practice, consultations, diagnostics, and treatment of patients.
Olena Datsenko Education Details
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Slovak Medical University, Bratislava, SlovakiaMd -
Chair Of The Oncology Of The Zaporizhzhay Medical Academy Of Postgraduate Education, ZaporizhzhayOncology -
Chair Of The Surgery And Proctology Of The Kharkiv Medical Academy Of Postgraduate EducationEndoscopy -
Chair Of The Oncology And Surgery Of The Kharkiv Medical Academy Of Postgraduate EducationOnco-Surgery -
Chair Of The Surgery And Proctology Of The Kharkiv Medical Academy Of Postgraduate Education, Kharkiv, UkraineColoproctology -
Faculty Of Fundamental Medicine, Faculty Of Fundamental Medicine, National Kharkiv University Named After V.N. Karasin, Kharkiv, UkraineCandidate Of Medical Science -
Chair Of The Surgery And Proctology Of The Kharkiv Medical Academy Of Postgraduate Education, Kharkiv, UkraineSurgery -
Faculty Of Fundamental Medicine, National Kharkiv University Named After V.N. Karasin, Kharkiv, UkraineMd
Frequently Asked Questions about Olena Datsenko
What company does Olena Datsenko work for?
Olena Datsenko works for Global Clinical Trials (Gct)
What is Olena Datsenko's role at the current company?
Olena Datsenko's current role is Medical Safety Specialist, MD, PhD.
What schools did Olena Datsenko attend?
Olena Datsenko attended Slovak Medical University, Bratislava, Slovakia, Chair Of The Oncology Of The Zaporizhzhay Medical Academy Of Postgraduate Education, Zaporizhzhay, Chair Of The Surgery And Proctology Of The Kharkiv Medical Academy Of Postgraduate Education, Chair Of The Oncology And Surgery Of The Kharkiv Medical Academy Of Postgraduate Education, Chair Of The Surgery And Proctology Of The Kharkiv Medical Academy Of Postgraduate Education, Kharkiv, Ukraine, Faculty Of Fundamental Medicine, Faculty Of Fundamental Medicine, National Kharkiv University Named After V.n. Karasin, Kharkiv, Ukraine, Chair Of The Surgery And Proctology Of The Kharkiv Medical Academy Of Postgraduate Education, Kharkiv, Ukraine, Faculty Of Fundamental Medicine, National Kharkiv University Named After V.n. Karasin, Kharkiv, Ukraine.
Who are Olena Datsenko's colleagues?
Olena Datsenko's colleagues are Iryna Golovach, Irina Ryzhkova, Ekaterina Zhukova, Konstantin Belousov, Marina Kovalchuk, Daria Podgórska, Natalia Krupina.
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Olena Datsenko
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