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110 000 руб.
не имеет значения
|не имеет значения|
июнь 2015 — август 2016
1 год и 3 месяца
АО ГЕНЕРИУМ, г. Москва.
Conduct and reporting of pre-study, initiation and routine monitoring visits
Communication with investigational sites and sites management
Ensuring the integrity of clinical data in adherence to all applicable regulatory guidelines, company’s SOPs and project-specific operating procedures
Assistance in feasibility studies
Negotiations of clinical trials agreements with the investigator sites and study budgets
Obtaining and review of required study documents from investigational sites
Project-specific training of sites and teams
декабрь 2014 — июнь 2015
MDP-group, г. Кемерово.
Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
Site management to ensure proper adherence to protocol, source data verification and assess CRF entries
Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
Assist with study protocol design, development and / or review if required
Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
Perform pre-study initiation, interim monitoring and close out visits as required
Carry out drug formulation administration procedures and documentation records
Ensure adequacy of drug shipment and drug accountability
Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
Organise / attend investigator meetings as required
Provide support to the Project Manager / Country Manager with ad-hoc tasks as required
февраль 2013 — февраль 2014
1 год и 1 месяц
EuroService, г. Кемерово.
• Market research in the fixed territory, determination of key clients, assessment of their potential, creation of sales forecasts;
• Sales plan accomplishment in the fixed territory;
• Establishment and maintenance of relations with hospitals, regular visits to existing and prospective clients, forming of requirement for hospitals departments;
• Increase of knowledge of company products according to marketing plans;
• Inclusion of preparations in hospital forms and treatment standards;
• Establishment and development of contacts with KOL;
• Organization and participation in marketing efforts (conference, round tables, schools, master classes);
• Maintaining plans and reports according to the established procedures.
ноябрь 2011 — ноябрь 2012
1 год и 1 месяц
Worldwide Clinical Trials , г. Кемерово.
• Collect Site Regulatory Documents and perform primary Quality Control of SRD;
• Perform all kinds of investigator site visits, manage investigator sites between visits;
• Assure adherence to the protocol, GCPs, SOPs and take necessary action to bring about compliance;
• Handle CRFs and DCFs and perform in-house CRF review;
• Facilitate adverse event reporting;
• Participate in preparation for and to assist during audit/inspection at investigator sites;
• Assist in preparation for and to participate in Investigator meetings and participate in study team meetings;
• Maintain a site specific part of the Trial Master File;
• Participate in feasibility studies.
октябрь 2009 — ноябрь 2011
2 года и 2 месяца
MMS, г. Москва.
Collect Site Regulatory Documents, Perform all kinds of investigator site visits, and manage investigator sites between visits; Facilitate adverse event reporting; Assist in preparation for and to participate in Investigator meetings and participate in study team meetings.
январь 2005 — октябрь 2011
6 лет и 10 месяцев
Agni, г. Кемерово.
Planning of sales, plan monitoring; Coaching sales representatives, making a list of tasks for sales representatives followed by monitoring and dual visits; Work with marketing department to expand the matrix of the Price by attracting new suppliers; Control over pricing; Work with VIP-clients; Development of promotional campaigns for clients.
GCP training. , г. Москва
Monitoring surveillance programs for patients with schizophrenia.. MMS, Moscow, Russia., г. Москва
Английский язык разговорный