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Experiences

Current Experience

  • Clinical Trial Project manager

    Moscow, Russia
    Since July 2013

    therapeutic area experience: oncology, tuberculosis, Rheumatology, coloproctology, Diabetes mellitus/ phases i-iii

    key areas of responsibility: client-facing role with the overall responsibility for study Planning and conduct; managing the cross-functional project teams (medical writers, logisticians, regulatory managers, financial specialists, data managers, Clinical Research Associates, Clinical Trial coordinators) and vendors; mentoring and Training of new employees. primary responsibility for budget Planning and tracking, Communication with the regulatory authorities.

    preparation and participation in bid defences.

    achievements: 7 successfully managed trials from the feasibility to the Clinical study reports.

    Therapeutic Area Experience: Oncology, Tuberculosis, Rheumatology, Coloproctology, Diabetes Mellitus/ phases I-III

    Key areas of Responsibility: Client-facing role with the overall responsibility for study planning and conduct; managing the cross-functional project teams (medical writers, logisticians, regulatory managers, financial specialists, data managers, clinical research associates, clinical trial coordinators) and vendors; mentoring and training of new employees. Primary responsibility for budget planning and tracking, communication with the regulatory authorities.

    Preparation and participation in bid defences.

    Achievements: 7 successfully managed trials from the feasibility to the clinical study reports.

Past Experience

  • Local Lead, Clinical Research Associate Moscow, Russia

    March 2013 --- July 2013

    therapeutic area experience: Rheumatology, Cardiology, phases ii-iii.

    key areas of responsibility: regulatory authority Communication, country budget, import, export; feasibility, site selection, stimulation of recruitment; work with central laboratories (covance, eurofins, quintiles) and other 3d parties; managing the study team including project related trainings; development of junior employees, e.g. trainings, co-monitoring; in addition full CRA responsibilities for several sites.

    achievements: recognized CRA performance in the key trial (award for recruitment, endpoints reporting and patient’s retention).   

  • Clinical Research Associate (CRA) Moscow, Russia

    March 2011 --- March 2013

    therapeutic area experience: Cardiology, phases ii-iii

    key areas of responsibility: local management (country level) in international trials; managing the study team including project related trainings; full CRA’s responsibilities: managing investigational sites through Clinical phase of project delivery (selection, initiation, monitoring and close-out visits), sdv and reporting, submissions to ec/ra, Training of site staff, support to site during the trial. mentoring and development of junior employees, e.g. trainings, co-monitoring.

  • Clinical Trial Coordinator (CTC) Moscow, Russia

    May 2009 --- March 2011

    therapeutic area experience: Cardiology, phases ii-iii

    key areas of responsibility: administrative support for project teams, co-monitoring site visits; organization of abroad investigators' meetings; Logistics support of Clinical trials; submissions and notifications to ethical committees and regulatory authorities; back-up for financial managers.

    achievements: recognized help with recruitment in the key trial  (award)

  • University Researcher (neuroscience) Nijmegen, The Netherlands

    September 2007 --- March 2009

    conducting animal experiments for a Pharmaceutical company johnson & johnson Pharmaceuticals (j&j): Preclinical Drug Development and Testing the animal model with different Drug substances. sharing experience with other specialists within the department and other laboratories involved in the project. concluding on the possibility to use the animal model for the further drug Testing (neurophysiology area). collaboration with the j&j Research and development department.

Personality

Self Assessment :
AdaptabilityCollaborationCommunicativeCoordinationCuriosityProactivityProblem solvingResponsibilityResult Oriented

Knowledge

Self Assessment :
Animal modelsAdverse Events (AE)BiologyCancer ResearchCardiologyClinical monitoringClinical trial budgetingCRFCROData ManagementGood Clinical Practice (GCP)Oncology Clinical ResearchPhases of clinical development (phase I to IV)Project ManagementStudy protocolsRegulatory submissions

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Design case record forms Monitor a clinical studyAdverse event reporting Develop clinical trial protocolsApprove monitoring reportsAssess site feasibilityCalculate trial timelinesCoach clinical staffCollaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCommunicate with sponsorContract approvalDesign case record form (CRF)Develop study budget

Education

  • Master of Science in Biology from Lomonosov Moscow State University in 2007

Training and Certification

  • Good clinical practice (Novartis) in 2012 Training
  • CRA development program, Edinburg Napier University in 2010 Training
  • Good clinical practice (OCT Rus) in 2014 Certification
  • Course on Laboratory Animal Science (certificate, Dutch article 9) in 2008 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Russian
Native
English
Professional Proficiency

Work Preferences

  • Notice Period:
    5 weeks
  • Positions I am interested in:
    Clinical Research Manager Clinical Trial Manager (CTM)
  • Locations I am interested in:
    The Netherlands
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    Yes

Area / Region

Russia

Others

Driving License
  • Yes

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