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Summary

• Developing comprehensive quality assurance plans for all clinical trial activities within the Clinic to ensure, that trials are conducted in compliance with the protocol, SOPs, ICH GCP, FDA and local regulatory requirements; • Selecting, developing & deploying licensed & non-licensed personnel to meet assigned objectives & tasks related to clinical research compliance. • Overseeing &/or directing team in identifying accountabilities for the areas of responsibility. • Preparing and executing quality assurance plans to ensure protocol and regulatory compliance; • Supervising data management tasks to ensure study data integrity; • Verifying that essential documents are accurate, complete, and maintained; • Coordinating of applicable follow-up activities. Assist in the development and implementation of action plans for external monitoring/audit follow-up; • Assisting in preparation and conduct of audits/surveys/inspections by FDA, CRO, institutional, and accreditation agencies;

Experiences

Current Experience

  • Clinical Research Manager
    Since November 2013
    • Developing comprehensive quality assurance plans for all clinical trial activities within the Clinic to ensure, that trials are conducted in compliance with the protocol, SOPs, ICH GCP, FDA and local regulatory requirements; • Selecting, developing & deploying licensed & non-licensed personnel to meet assigned objectives & tasks related to clinical research compliance. • Overseeing &/or directing team in identifying accountabilities for the areas of responsibility. • Preparing and executing quality assurance plans to ensure protocol and regulatory compliance; • Supervising data management tasks to ensure study data integrity; • Verifying that essential documents are accurate, complete, and maintained; • Coordinating of applicable follow-up activities. Assist in the development and implementation of action plans for external monitoring/audit follow-up; • Assisting in preparation and conduct of audits/surveys/inspections by FDA, CRO, institutional, and accreditation agencies;

Past Experience

  • Head of Endocrinology Department
    January 2010 --- December 2013
    • Consulting and Providing appropriate care for the endocrinology Patients • Overseeing staff assigned to day-to-day clinical activities of the Endocrinological Department • Evaluating and training clinical staff • Supervising and overseeing Endocrinological Clinical Trials as PI (Principal Investigator)

  • MD Endocrinologist
    September 2005 --- January 2010
    • Consulting and providing appropriate care for the patients • Acting as CRC (Clinical Research Coordinator) and assistant to PI for Clinical Trials

Knowledge

LinkedIn Assessment :
Microsoft OfficemanagementMicrosoft ExcelMicrosoft WordResearchPowerPointSalesLeadershipTrainingClinical researchClinical trialsGCPClinical DevelopmentHealthcareLife Sciences

Training and Certification

  • Endocrinologist Certificate Certification
  • General Physician Certificate Certification

Area / Region

Tbilisi, Georgia

Others

Driving License
  • No