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Clinical Data Manager - Poland  

KCR (company)


Posted on : 19 May 2017

Project Description

The duties associated with the role include:
  • Coordinating and performing the collection and processing of CRF data. 
  • Performing data management activities, including: data receipt, data entry, and initial and final data review, and discrepancy resolution. 
  • Using manual and automated methods to perform clinical data review and medical review to ensure the overall integrity and consistency of the clinical trial data. 
  • Encoding unrecognized terminology entered into the database using MedDRA and other dictionaries. 
  • Identifying and resolving central and local data quality issues and maintaining standard central and local data management practices. 
  • Coordinating and performing DM set-up process, CRF/eCRF set-up, collector design, edit definitions, report requirement definition, requirement documentation and testing. 
  • Ensuring consistency in execution across assigned trial portfolio.  

  • University/college degree in paramedical or technical discipline 
  • A minimum of 5 years of experience in clinical data management, clinical research or in a clinical or bio-medical area 
  • Excellent English skills (both written and verbal) as well as strong communication and interpersonal skills, with an ability to work cross functionally in a globally diverse environment 
  • Strong computer skills, with preferred experience in one or more EDC tools and with basic knowledge of late stage clinical development process 
  • Excellent knowledge of ICH/GCP, including understanding of regulatory requirements and European Directives 
  • Other desired characteristics include good organization, analytical and presentation skills along with the ability to work independently and efficiently