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Experiences

Current Experience

  • Clinical Project Manager (CPM) Moscow, Russia
    Since May 2016

    Project management of local and global post authorization studies across various therapeutic areas. Leading core study team to achieve team deliverable within agreed timelines and in accordance with scientific, qulity and regulatory requirements. People management responsibilities (12 reporters - Study specialists and MSLs).

    Trial management responsibilities: management of all aspects of trial conduct from trial set up to end of trial, including drafting protocol, CRF, ICF and all other study related documents, budget formulation for local projects (based on FMV) and budget ratification for global projects.

    Study site contracts negotiation, site training (during investigators meeting or via phone). Site co-monitoring on demand (both SIV, SMV, COV).

    Performing quality review process as auditor in accordance with Quality Review Plan and SOPs.

    Liaising with external service providers and internal departments to ensure compliant, effective and efficient project conduct. Performing external suppliers selection. Local submissions to competent authorities, ethic committees.

Past Experience

  • Associate Director Clinical Operations Yaroslavl, Yaroslavl Oblast, Russia
    August 2015 --- May 2016

    Leading Clinical operations of the Russian affilate of a small size CRO. Implementing and running Quality Assurance activities at the company level. Performing training to CRA team to ensure optimal perfomance, compliance with SOPs and regulations.

    Support feasibility process and ensure adequate site selection. Support the planing, management and execution of study-related activities from study start-up to clos-out procedures.

    Identifying and reviewing process issues whithin internal quality audit and recommending improvements when required.

    Accompany CRA in site evaluations, initiations, monitoring and close-out visits. Identifies best practices that will contribute to overall operational effectiveness.

  • Clinical Research Coordinator
    August 2013 --- May 2016

    Working in phase I-IV clinical trials as clinical research coordinator and investigator. Performing ICF activities. Working with EDC (Oracle inForm and RDC), various IWRS systems. Maintain all required documentation in the research regulatory binder. Wide range of IMP-related activities such as drug accountability etc. Maintain records of each study subjects' status in the study. Communicating with CROs, Sponsors, IRB. Development and implementation of SOPs for First in Man unit and for clinical trial site. Strong knowledge of ICH-GCP and National regulatory documents.

    Detailed:

    • Design and maintain organizational tools to conduct the study accurately and in compliance with GCP.
    • Ensure the safety and welfare of the study subjects by conducting follow-up phone calls.
    • Read the Sponsor's protocol to ensure that all study activities are completed correctly and completely.
    • Communicate and work with the IRB to obtain necessary IRB approvals for protocol, advertisements, and the informed consent before initiation of study.
    • Train other site personnel, and medical staff, on the specifics of implementing the protocol (as designated by the PI).
    • Recruit and screen potential study subjects according to the protocol's inclusion and exclusion criteria.
    • Follow correct informed consent procedures.
    • Schedule study subjects' visits and perform defined activities of the study completely and accurately.
    • Report all adverse events and unanticipated problems to the PI.
    • Maintain adequate and accurate case histories for each study subject and record all observations in the source document and on the Case Report Form (CRF) during the study.
    • Maintain all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies) (ICH 1.51).
    • Complete the CRFs for the study accurately, completely, and in a timely fashion. Ideally, CRS are completed at the conclusion of the study visit or within 24 hours post completion.
    • Assign study subject numbers and maintain accurate and complete records of the receipt, administration, and return of all clinical supplies.
    • Maintain all required documentation in the research regulatory binder.
    • Maintain records of each study subjects' status in the study.
    • Communicate with the Sponsor regarding study activities as necessary.
    • Meet with the Sponsor's representatives to discuss the conduct of the study and review study data.

    Facilitate proper clearance to access original records of the study for inspections, audits, etc. from external and institutional regulatory authorities (i.e. Sponsor, FDA) in accordance to appropriate policies and procedures.

  • Field Clinical Research Specialist Yaroslavl, Yaroslavl Oblast, Russia
    September 2012 --- August 2013

    • Read the Sponsor's protocol to ensure that all study activities are completed correctly and completely.
    • Schedule study subjects' visits and perform defined activities of the study completely and accurately.
    • Report all adverse events and unanticipated problems to the PI.
    • Complete the CRFs for the study accurately, completely, and in a timely fashion. Ideally, CRS are completed at the conclusion of the study visit or within 24 hours post completion.
    • Assign study subject numbers and maintain accurate and complete records of the receipt, administration, and return of all clinical supplies.

    Maintain records of each study subjects' status in the study.

Personality

Self Assessment :
Analytical thinkingAttention to detailCollaborationCommunicativeCoordinationCritical thinkingEfficiencyFlexibilityOrganizationProblem solvingResponsibilitySelf-disciplineStrategic thinking

Knowledge

Self Assessment :
Good Clinical Practice (GCP)Clinical trial audits and inspectionsClinical trial designClinical Trial Management System (CTMS)Clinical trial managementClinical monitoringProject ManagementProject PlanningProblem SolvingInternal medicineInternational Project ManagementPharmaceutical IndustryPharmaceutical DevelopmentElectronic Data Capture (EDC) Clinical trial budgeting
LinkedIn Assessment :
ICH-GCPClinical trialsClinical researchProject ManagementProject PlanningTeam ManagementVendor ManagementProblem SolvingConflict ResolutionEDCPhase Forward InFormOracle RDCInternal medicineCardiologyDrug InteractionsMicrosoft OfficeApple KeynoteApple Pages

Skills and Expertise

Self Assessment :
Analytical skills Analyze data Assure medical quality Build and manage the Trial Master File (TMF) Control data Develop clinical trial protocols Interact with physicians Monitor a clinical study Report data Search literature on clinical trialsAdverse event reportingWritten presentationManage clinical trial files/documentsPrepare internal auditsFollow-up of internal auditsCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Manage trial master file (TMF)Manage Clinical Trial Management System (CTMS) Update Clinical Trials Management System (CTMS) Manage multiple projectsManage study budgetSite management

Education

  • General Physician in Clinical Pharmacology from Yaroslavl State Medical Academy in 2014
  • MD in General Medicine from Yaroslavl State Medical Academy in 2013

Training and Certification

  • Advanced monitoring in clinical trials in 2016 Training
  • GCP in 2016 Training
  • GCP in 2014 Training
  • GCP in 2012 Training
  • Level 1 Certificate in ESOL International (Spoken) (Communicator B2) in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Russian
Native
English
Full Proficiency

Work Preferences

  • Positions I am interested in:
    Auditor Clinical Operations Manager Global Clinical Project Manager (GCPM, GTM) Clinical Project Manager (CPM) Clinical Project Leader Quality Assurance (QA) Manager Team Leader Senior Clinical Research Associate (CRA) Clinical Research Physician Medical Monitor
  • Work From Home:
    Yes, 0 to 5 days per week
  • International:
    Yes

Area / Region

Moscow, Russia

Others

Driving License
  • Yes