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More: Offices, Career at GCT

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Irina Ryzhkova, M. Sc., Deputy Director, Corporate Lawyer

Irina joined GCT back in 2012 as a corporate lawyer. Being originally from a very different field, – her first degree is in Roman linguistics and she served as a French language teacher at a school at one of the leading Pedagogical Universities in St. Petersburg, Russia, – in 2009 she decided to become a lawyer. Before Irina started her career at GCT, she already had 4 years of prior experience and law school behind her. She went through several trainings for non-clinical CRO professionals and acquainted herself with the industry very fast. Irina’s managerial mindset and composure contributed to a rapid promotion to a deputy director of the GCT Russian office. As a corporate lawyer, Ms. Ryzhkova performs legal control of corporate activities and as a Deputy Director she oversees and assures smooth functioning of the staff and departments at the company’s biggest office in Central-Eastern Europe. Irina is involved in the most important company processes such as study set up in terms of site contracting, financial planning and control during the projects, as well as activities within the Human Resources field. (more…)

Veronika Goriachikh, MS, Head of Central Depot

Ms. Veronika Goriachikh, an alumna of Saint Petersburg State Chemical Pharmaceutical Academy joined GCT in 2013 as a clinical research pharmacist for projects conducted by the company in Russia. In pursuit of expanding her qualification, Veronika completed a special course on logistics and customs procedure for clinical trials, and shortly after that she was appointed Head of Russian Central Depot at GCT.

Veronika’s responsibilities include coordination of the import of IMP, medical devices and supplies for clinical trials, provision of support on the export of biological samples from Russia to Sponsor’s Laboratories around the world, – all in compliance with Good Storage Practice, Sponsor/Manufacturer guidelines, Standard Operating Procedures, and applicable national standards.
Veronika continues her professional growth with the company by participating in relevant trainings and audits of the 400 sq. meters warehousing facility, which she operates. An important part of her responsibilities is a thorough evaluation of all possible complications and IMP-related delays which can result in unplanned expenses for the Client. Following the outcome of such evaluation, GCT team communicates potential issues to Client and undertakes the necessary measures to prevent them. For local CRO projects it is crucial to have on staff a highly skilled and competent member of the team, such as Veronika. (more…)

Anna Kuzmicheva, MA, Director, Business Development

Anna KuzmichevaPrior to becoming an employee of GCT Business Development Department back in Jan 2013, Anna held several positions in sales and customer service. In four years at GCT she has gracefully gone from Business Development Associate to Director of Business Development Department due to the natural persistence and ability to put her heart and mind to the great work. Anna is a multitasker, who contrives to manage existing GCT accounts, bring new business to the company, oversee marketing activities and participate in company’s strategic development decisions – all between traveling to meetings at GCT offices in CEE and conferences around the globe. (more…)

Samer Hilan, M.D., Project Manager, General Director GCT Bulgarian office

Dr. Samer Hilan leads the Bulgarian office in Sofia, and acts as a Project Manager for studies conducted in the country since 2014.

Samer is a Medical Doctor with over a decade of experience in clinical trials industry. Following his graduation from the Medical University of Sofia in 2001, he received a PhD Scholar and pursued his education at the University of Rostock – Institute of Physiology, Germany, further completing the residency training at University Hospital Aachen, Germany.

During his career in clinical research, he got to be involved in all the essential parts of a drug development cycle – from drug discovery laboratory, to the work in the field with patients as CRA and SCRA, from assurance of adherence to the protocol to providing pharmacovigilance support at the UK based CRO – he gained a pervasive knowledge that he uses in his current Project Management position. Dr. Hilan’s therapeutic expertise varies from Neurology to Cardiology and Endocrinology and his skills in the pharmaceutical industry include among others GCP, CTMS, clinical development, EDC and regulatory.
(more…)

Alexey Vinogradov, M. D., Project Manager

Dr. Alexey Vinogradov took up the Project Management position at GCT Russian office in 2014. He swung into action right away, having started work on a crucial local Russian study in CNS area and a multicountry project in gastroenterology involving dozens of sites and aggressive enrollment timelines. After Alexey graduated from Pavlov Medical University with the medical degree, he completed internship in Surgery and then residency in Urology working at one of the Hospitals in St. Petersburg, Russia. His career in Clinical Research field started in one of the mid-sized international CROs. Alexey gradually advanced from CRA to SCRA and Clinical Lead thereafter, bringing his medical background and work experience for the benefit of the projects he was involved in.

Since his assignment as a Project Manager, Alexey has deepened his skills and knowledge related to coordination and control of multicentre clinical studies. His experience covers management of multiple parties working on a time-critical project together: CRO clinical team, data management and statistics team, site administration and investigators, as well as a number of vendors. His therapeutic area expertise is very wide, some of the fields are: neurology, psychiatry, gastroenterology, oncology, cardiovascular, endocrinology, and reproductive health. (more…)

Irina Golovacheva, MD, Manager, Regulatory Affairs, Russia

Dr. Irina Golovacheva oversees the regulatory process from the initial study submission and receiving an approval up until end of study notifications for each project conducted by GCT in Russia. Irina is located in Moscow, within easy reach to the Ministry of Health and other agencies. Her responsibilities comprise of filing necessary applications, ensuring control of all Sponsor’s study documents to be submitted to the state regulatory bodies, and further – handling all interactions with MoH, Rosdravnadzor (Federal Service for Surveillance in Healthcare) and other authorities. Irina dedicates a fair share of her time for research to stay on the cutting edge with changes in the clinical trials regulations, combining it with regular participation in industry trainings and official seminars on the same topic. These facts, put together with her critical thinking ability and detail-oriented approach assure 100% successful regulatory track record for GCT and our Sponsors.

Dr. Golovacheva has extensive background in the Russian healthcare and pharmaceutical industry. Previously, she held positions in Regulatory Affairs and Pharmacovigilance for local CRO and Pharma companies and prior to that was involved in scientific research at the “Scientific Centre of Children Health” institution under the Russian Academy of Medical Sciences for almost a decade. She graduated with a medical degree from Moscow Medical Academy n.a. I.M. Sechenov, the oldest and the largest national medical higher educational institution in the Russian Federation. (more…)

Dmytro Mnozhynskyy, M.D., Project Manager, General Director, GCT Ukrainian office

Dr. Dmytro Mnozhynskyy serves as a General Director of the Ukrainian office – the second biggest company’s office in the region and is a Project Manager with 13+ years of experience in international studies management.

Dr. Mnozhynskyy has graduated from the Ukrainian National Medical University in 1998 with a medical doctor’s degree. Urologist by training, he came to the clinical trials industry after a couple of years at the Department of Kidney Transplantology at Institute of Surgery and Transplantology of Medical Academy of Science in Kyiv. The following two years Dr. Mnozhynskyy has spent in Germany where he served as a Clinical Project Coordinator at one of the German based CROs. Prior to joining GCT in January 2007, Dr. Mnozhynskyy also held positions of Clinical Research Associate and Clinical Lead at one of the global CROs in Ukraine. (more…)

Maria Seregina, MSc, CRA

Maria has recently graduated from St. Petersburg State Chemical Pharmaceutical Academy with a specialist degree and decided to begin a carrier in clinical research with GCT after holding several positions in sterilization process chain and organization of production. She joined the company in 2015 at the entry-level position of Research Associate. Maria completed necessary SOP and GCP trainings, rapidly gained the necessary skill set and next year was promoted to a CRA due to her ability of balancing strong people skills and detail-attentive “checklist mentality” just in the right ratio for the job.

Ms. Seregina has experience in Gastroenterology and Neurology being at the times involved in monitoring several studies GCT conducts in Russia. Her tasks include ensuring that patients meet the inclusion criteria, reviewing CRFs to guarantee that they have been filled out correctly and checking clinical trial supplies to be stored and distributed properly, and other necessary site-related activities. (more…)

Vladimir Seredyuk, MD, Quality Assurance Manager

Vladimir Seredyuk

Dr. Seredyuk has joined GCT QA team in 2014. Vladimir is a licensed physician with 10 years of experience in different areas of clinical research. Following the award of his medical degree in the Medical-Military Academy n.a. S.M. Kirov in St.-Petersburg, Vladimir has accomplished a special course of English at Defence Language Institute and then an Officer Basic Course at US Army Medical Center & School in San Antonio, Texas. After a few years he decided to start a career in clinical research and became CRA for one of the Eastern European CROs. Holding different positions, Vladimir has successfully passed a number of EMEA and FDA inspections and completed the auditing course to become a QA professional.

Vladimir is currently in charge of overseeing all components of the quality process related to clinical trials that GCT conducts. During his time with the company, Vladimir has improved the existing and added new standard operating procedures for trial execution and overall company operations, provided regular trainings on ICH GCP and study specific trainings; he is closely involved in investigator and site pre-assessments and selection process for all projects. He has just the set of skills that are highly valuable in the compound process of clinical research: he is ready to multitask, reacts rapidly towards finding the solution to any situation, is creative and determined yet carefully contemplating the consequences. Dr. Seredyuk is not only carrying out internal audits for company’s trials, but is also engaged as an independent auditor by Sponsor companies to inspect the work of other CROs and sites. Whenever necessary, Vladimir is able to provide Project Management support to GCT clinical team due to the experience in wide range of therapeutic areas, including the company’s core areas of Neurology, Oncology and Gastroenterology. (more…)

Nataliya Katsnelson, M.A., Business Development Manager, GCT Princeton office

Nataliya Katsnelson

Ms. Nataliya Katsnelson joined GCT Business Development team in early 2014 at an entry-level associate position. Energetic and ambitious, she quickly gained insight into the clinical research field and took on several business development accounts. Besides client relationship management, Nataliya has been actively participating in various concurrent activities: marketing and brand management, project budgeting and proposal development, event planning. Dedication, commitment, and continuous new ideas’ generation resulted in her promotion to the Business Development Manager position by the end of last year.

Nataliya got her Master’s Degree in Public Relations in one of the leading universities St.Petersburg, Russia, and moved to the United States shortly after. Her work background includes sales and event organizing.

Being a Russian born gives her deep understanding and knowledge of systems, approaches, and mentality which influence conducting clinical trials in the region and allows her to act as a competent liaison between Sponsors and local teams. (more…)

Sergiy Nayda, M.D., Senior CRA, GCT Ukrainian office

Sergiy Nayda

Dr. Sergiy Nayda is the eldest Sr. Clinical Research Associate in the company. A pediatric physician, he completed his internship in anesthesiology and intensive care therapy prior to joining GCT Ukrainian team as a CRA back in 2008. The first project assigned to Sergiy was an Acute Ulcerative Colitis study involving 15 clinical sites throughout Ukraine. In parallel Sergiy was involved in a Phase III Breast Cancer study.

During the following years Sergiy has achieved extensive experience and deep knowledge in various late-stage clinical trials. While working on a complex dementia study, he was responsible for monitoring 150 randomized patients in Ukraine and 50 patients in Russia, which helped Sergiy to develop comprehensive communication skills within a big team and fast paced environment. He has thorough approach to the SDV process and is very attentive to details. Participation in multiple audits has contributed to his understanding of applying GCP and other clinical trial regulations in real life situations. (more…)

Roxana Darie, MBA, General Director/Legal Affairs, GCT Romanian office

Roxana Darie

Ms. Darie leads GCT regional office in Bucharest, Romania, since late 2015. While she is quite new to the company, her experience in clinical research field is close to a decade: Roxana previously held the positions of COO, Country Manager, and Legal Affairs Manager for several European CROs. She is a high profile manager, with experience in business and international law, leadership and strategic development.

From the moment I started working at GCT I have come to realize there is an outstanding sense of team spirit combined with a strong work ethic. Therefore, if there was only one aspect I had to choose from the multitude of benefits working with the company that would be the GCT Team. It is really impressive to see people with different academic backgrounds come together and give their valuable input on a project, from the beginning to the end, from the business development to clinical, quality, financial, legal and all the way to aspects. I am privileged and honored to be a part of such committed and professional workforce. (more…)

Velislav Zarev, MSc, CRA

Velislav Zarev

Mr. Zarev is one of the newest GCT employees; he smoothly joined our Bulgarian team in 2015. He came to the arena of clinical trials from the field of life sciences, following his pursuit to work in this life changing industry.

His most recent experience as a CRA is in the field of neurology, where he is responsible for investigative sites interactions and clinical monitoring of the data for the Phase III multinational antiepileptic study. (more…)

Anton Romanov, MSc, Event Manager

Anton Romanov

Anton has enormous experience within the company’s operations from the perspective of marketing activities and event organization in Russia. He oversees and plans smaller events, such as Sponsor visits and audits, as well as large scale investigator meetings. For the latter he makes sure that these essential clinical study start-up events are both effective and convenient for the participating medical staff, researchers, coordinators, and Sponsors. Anton has carried out different functions, including general meeting supervision and all necessary travel, accommodation, entertainment, meeting venue, translation, and administrative arrangements.

Anton’s commitment to GCT, his ability to multitask and switch gears at the drop of a hat made him the valued and actually the oldest member of GCT Russian team: he has been with the company from its very inception! In 2006 while already working at GCT for a few years he graduated from the St. Petersburg University of Public Administration. (more…)

Alina Mitrofanenko, MSc, Project Manager

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Mrs. Alina Mitrofanenko is a GCT Project Manager, with the experience of handling international studies in neurology, ophthalmology, obstetrics, haematology, and others. She joined GCT Russian office in 2009, making her a long-time member of the team.

Alina started her career in clinical research from an entry-level position, using her talent and dedication to gradually move forward. During the years, she held the roles of Clinical Research Coordinator and Associate Project Manager, which were followed by a further promotion to the Project Manager position. By such step-by-step advancement, Alina gained deep understanding of the clinical studies’ processes and mechanisms from different viewpoints. (more…)