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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 science)" >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 science)" >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 science)" rel="nofollow">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 science)" rel="nofollow">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; • 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

Knowledge

LinkedIn Assessment :
Microsoft OfficemanagementMicrosoft ExcelMicrosoft WordResearchPowerPointSalesLeadershipTrainingClinical researchClinical trialsGCPClinical DevelopmentHealthcareLife Sciences

Training and Certification

  • Endocrinologist Certificate in 0000 Certification
  • General Physician Certificate in 0000 Certification

Area / Region

Tbilisi, Georgia

Others

Driving License
  • No

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