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Alexander Loginov

, Russia

Phone: xxx-xxx-xxxx

Email: xxx@xxxx.xxx



  • Looking For: project manager, clinical research associate

  • Occupation: Management

  • Degree: Master's Degree

  • Career Level: Experienced

  • Languages: English, Russian

Career Information:

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Highlights:My experience appears to be concentrated in clinical trials management across all developmental stages, with exposure to preclinical research and operational aspects of drug development. Alexander Loginov has 16 years of work experience, with 12 years of management experience, including a low-level position.

Skills:clinical study, clinical trial, project management, study management

Certification:GCP certification in 2008, 2017.


Experiences:

Clinical project manager 07/2016 - current
Alvogen, Moscow, Russia
My experience appears to be concentrated in clinical trials management across all developmental stages, with exposure to preclinical research and operational aspects of drug development.
Cooperate in the strategy development and coordinate clinical activities in relationship with the registration of the in-licensed medicinal products. Align to a submission strategy in the clinical part of the projects. Coordinates all aspects of clinical trial management activities: Collect information from Regulatory Affairs within Alvogen regarding the local clinical requirements for supporting of Marketing Authorization Applications (MAAs); Coordinates single & multi center trials, as needed; Contacts Contract Research Organizations (CROs), collects quotes (budgets proposals), summarizes & presents to Management team; Reviews study protocols, clinical expert reports and any other clinical documents requested for the registration purposes; Supports MAAs, regulatory authority applications and approvals – for the local clinical trials conduction and medicinal products; Manages the clinical trials for which he has been assigned by the Head of Clinical Operations CEE throughout study conduct; Coordinate products samples delivery for local Comparative Dissolution Profiles (CDPs) and clinical studies, if needed; Review CDP data & reports; Review of the clinical part of the dossiers & related modules, if needed.--
Clinical Research Specialist 02/2014 - 06/2016
Dr. Reddy's Laboratories Ltd., Moscow, Russia
Industry: Pharmaceuticals
Alexander Loginov's experience appears to be concentrated in clinical trials management across all developmental stages, with exposure to preclinical research and operational aspects of drug development.
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Medical Translation Editor, Reviewer and Proofreader 06/2010 - 01/2014
Janus Worldwide, Moscow, Russia
Industry: Medica and communications
Achieved the growth of the company translators’ proficiency in English medical terminology after validation of the choice of specific Automatic Translation System for the use in Medical Information department.
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Medical Advisor 08/2008 - 11/2010
Abbvie Inc, Moscow, Russia
Industry: Pharmaceuticals
Guaranteed the approval by Ministry of Health of 2 phase IV clinical trials by involvement in study control and execution by contributing operational experience and expertise: provides input into study documentation design.
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Medical Advisor 09/1997 - 03/2008
Sanofi Pasteur, Moscow, Russia
Industry: Pharmaceuticals
Designed medical-education plan and communication plan for 5 products with the marketing team. Implemented appropriate internal medical communication and shared the vision for the product internally by performing 2 training sessions annually for medical representatives and the company personnel. Developed the strategic medical actions plan for seven vaccines by providing expertise and strategic input.
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Research Fellow 09/1992 - 08/1997
Research Institute for pediatric Hematology, Moscow, Russia
Industry: Life, Physical, and Social science
Contributed significantly in development of three laboratory SOPs. Participated weekly in ongoing research workshops and research meetings. Presented results as verbal presentations and written reports for three studies. Maintained up to date, complete, accurate, and organized study files. Warranted the laboratory diagnostics of leukemia, lymphoma, anemia and other hematological conditions in children using flow cytometry methods. Set up and realized the proficiency development plan for laboratory personnel.
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Education:

Russian National Research Medical University 09/1986 - 06/1992
Moscow, , Russia
Degree: Master's Degree
Major:Internal Medicine
I have graduated from Russian National Research Medical University (also known as Russian State Medical University) in 1992.


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