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Experiences

Current Experience

  • Clinical Research Consultant


    Since April 2014
    providing large scale services related to Clinical Trial set up, monitoring and site management. in the role of Project Manager/clinical lead my experience include taking a Leadership role for project activities related to monitoring functions. developing and implementing study materials/tools such as monitoring plan, newsletters, flowcharts, and manuals. reviewing visit reports, facilitating CRA Training, managing budget, tracking client deliverables, keeping open Communication with project team, including client and third party vendors to ensure Compliance with the ich-gcp, FDA and local country regulations, project expectations and high level quality standards. Providing large scale services related to clinical trial set up, monitoring and site management. In the role of project manager/clinical lead my experience include taking a leadership role for project activities related to monitoring functions. Developing and implementing study materials/tools such as monitoring plan, newsletters, flowcharts, and manuals. Reviewing visit reports, facilitating CRA training, managing budget, tracking client deliverables, keeping open communication with project team, including Client and third party Vendors to ensure compliance with the ICH-GCP, FDA and local country regulations, project expectations and high level quality standards.

Past Experience

  • Clinical Operations Lead

    December 2007 --- February 2012
    main responsibilities • overall accountability for the execution of the Clinical operations Strategy • coordinate the functional team members and their activities across all geographies • communicate with internal and external customers as well as third party vendors • manage study start-up activities • develop study plans, tools and forms • identify, organize and deliver study specific Training in collaboration with other project team members • evaluate, identify and constantly monitor resourcing needs for clinical execution of project • address identified and escalate site issues and drive to closure • recognize areas of potential problems and provide input to contingency plans • monitor study timelines, Patient Recruitment, retention and Data cleaning to ensure successful outcome of the project • oversee maintenance and quality check of central files • maintain and assure quality of work generated and escalate and follow up as appropriate • collaborate with project team on database lock activities

  • Sr. Clinical Research Associate

    January 2006 --- November 2007

  • Clinical Research Associate (CRA)

    May 2000 --- August 2005

Knowledge

LinkedIn Assessment :
Pharmaceutical IndustryClinical trialsoncologyBiotechnologyClinical DevelopmentSOPGCPMedical DevicesHealthcareRegulatory affairsClinical research

Education

  • in from Boston University School of Medicine in 2008
  • Master's degree in MSc from Tartu Ülikool in 0000

Training and Certification

  • BU School of Medicine Clinical Research Certificate in 0000 Certification

Area / Region

Tartu, Tartu linn, Estonia

Others

Driving License
  • No

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