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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 Certification
  • IELTS Certificate Certification
  • IELTS Certificate Certification

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Full Proficiency

Area / Region

Berlin, Germany

Others

Driving License
  • Yes