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Experiences

Current Experience

  • Senior Clinical Monitoring Associate / Senior Inhouse site manager


    Since May 2016

Past Experience

  • Clinical Monitoring Associate II

    November 2014 --- April 2016

  • Clinical Monitoring Associate I

    April 2013 --- October 2014
    in-house site management of sites in germany, austria and switzerland including Qualification, initiation, monitoring and termination preparation, pre-initiation document collection, database lock support, issue resolution, contract-amendment-development, ensuring timely and high quality Data entry Compliance from site, patient enrollment management

  • Data Entry Operator (part time) / Administration Associate

    September 2012 --- April 2013
    supporting the monitoring department, Quality Management and medical Data Management: Quality Control of amendment submission documents, SOP review and Translation, medical coding; trial master file review; study Data entry

  • Research Operations Assistant Trainee

    May 2012 --- August 2012
    accompanying and supporting of monitoring visits; follow-up of site specific problems concerning invoices; obtaining of study documents; issue resolution according to quality checks performed from central file; labeling, tracking and filing of study documents according to the central file maintenance plan; creating of file notes; work according to parexel internal sops

  • Data Entry Operator (part time)

    September 2011 --- February 2012
    study Data entry via SAS 9.2

  • Data Management and Monitoring Department Trainee

    July 2011 --- August 2011
    activities in the areas of Data Management and monitoring: accompanying an Interim monitoring visit; writing a monitoring report; creating test patients in SAS 9.2 on the basis of the data Validation plan and the annotated crf; work according to icrc-weyer internal sops

Knowledge

LinkedIn Assessment :
CROClinical researchClinical monitoringTeamworkReliabilityorganizational skillsTime ManagementICH-GCPTMFISFCRFsattention to detailProactivitywork experience abroadICFImpact HarmonyInform 4.6Project Managementwork according to SOPsMotivationRAVEDatalabsPediatric OncologyRheumatoide ArthritisAtopic Dermatitis

Education

  • Bachelor of Science (Hons) in Clinical Research in Clinical Research from University of Wales, Cardiff in 2013

Training and Certification

  • BSc (Hons) in Clinical Research in 0000 Certification
  • IELTS Certificate in 0000 Certification
  • IELTS Certificate in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Full Proficiency

Area / Region

Berlin, Germany

Others

Driving License
  • Yes

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