Vladimir Shkeda
Clinical Research Associate / Project Manager of the bioequivalence studies at Pharmstandard LLC- Claim this Profile
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Русский Native or bilingual proficiency
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English Professional working proficiency
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German Limited working proficiency
Topline Score
Bio
Credentials
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Guidelines for organization and conducting Clinical Trials according to Good Clinical Practice (ICH GCP).
-Mar, 2014- Nov, 2024
Experience
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Pharmstandard LLC
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1 - 100 Employee
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Clinical Research Associate / Project Manager of the bioequivalence studies
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May 2016 - Present
Perform work on the preparation, monitoring and maintenance of clinical trials. Monitoring the budget and timing of the projects. Control over the performance of work by contract research organizations, making payments in accordance with contracts. Development of documentation of clinical trials.Participation in the selection of contract research organizations, medical organizations, analytical laboratories. Conducting audits of contract research and medical organizations for compliance with established requirements. Evaluation of intermediate and final results of clinical studies. Registration and verification of documentation on the clinical part of the registration dossier. Carrying out risk analysis of the safety and efficacy of drugs according to the results of clinical studies. Participation in the planning of a registration / post-registration clinical trials strategy with an assessment of the cost and duration of the study. Ensuring the quality of clinical trials, communication with the controlling authorities at the federal and territorial levels. Support with the regulatory activities, work under additional requests upon the Health Authorities deficiency letters within drug products registration. Preparation of the dossier for drug product in accordance with the requirements of the Eurasian Economic Union, the definition of the scope of work within the process. Providing management and storage of clinical research documentation in accordance with current legislation and local procedures of the clinical research team. Participation in the processes of developing and regularly updating the procedures of the medical department and local procedures / work instructions of the clinical research team. Show less
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Sanitary inspector & epidemiologist
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Sep 2010 - Apr 2016
Conduct routine inspectional activities of food service establishments to assure safe, wholesome and sanitary food and food products, wherever produced, processed, distributed, transported or served. Authorize issuance of licenses and permits for food establishments, or deny if necessary. Investigate food borne illnesses. Inspect recreational areas and water to assure that recreational and swimming areas are designed and maintained so as to prevent health and safety problems. Conduct routine housing (shelter) inspections to assure adequate, safe and healthful housing for all people. Interview people on-site for additional information. Conduct follow-up re-inspections. Submit findings and recommendations to supervisor. Compile and submit a detailed report of the findings to supervisor. Request and refer to appropriate departments when technical expertise is required. Investigating diseases involves the collection and analysis of health data through field research, observation, questionnaires and studies. During disease outbreaks, apply knowledge of how and why communicable diseases spread to make recommendations on containment and treatment. Monitoring the epidemiology situation on a regular basis, report to local and state health agencies and evaluate data collected during the outbreak. Show less
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Roche
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Switzerland
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Biotechnology Research
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700 & Above Employee
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Country Clinical Trial Assistant
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Feb 2014 - Oct 2014
Coordination of logistic processes of local study team, assistance in ordering and distributing the study-related supplies, coordinating and tracking the distribution and subsequent retrieval of required documents, including but not limited to contracts, invoices, applications of Health Authorities and Ethics Committees, protocols, ICFs (Informed Consent Form) and amendments, IB (Investigator’s Brochure), ensuring proper documents registration in the TMF (Trial Master File) and CMF (Center Master File) in accordance with ICH-GCP and Company procedures. Create, fill out and maintain relevant information about protocols in the Clinical Trial Management System (CTMS) on a regular basis. Coordinating payments to investigators and hospitals, organization and coordination of internal and external meetings, trainings and travels (visa, tickets, transfer). Show less
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Education
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2004 - 2010
First Moscow State Medical University named after I.M. Sechenov (Higher education)
Epidemiology, Hygiene.
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