Clinical Data Manager

Clinical Data Manager


  • Communication with the sponsor and other collaborators of the project regarding data management issues.
  • Production and Maintenance of key study related documentation (Data Management Plan, Data Validation Plan, EDC specifications, Data Management Report) according to standard operating procedures.
  • CRF design and review determining the data collection requirements of the study through review of the protocol and other supporting documentation.
  • Creation of the edit-checks included the Data Validation Plan as well as the listings and reports as agreed with the sponsor.
  • Coordination of all data cleaning activities including DCF/query handling and coding management.
  • Coordination of external data transfer, integration and reconciliation with the study database.
  • Coordination and finalization of database lock activities in close collaboration with the sponsor, statistician and other parties.
  • Development of standardization (templates and processes).
  • Coaching of more junior staff


  • University degree, preferably in science
  • Thorough knowledge of the Data Management process
  • Minimum 5 years of successful Clinical Data Management experience
  • Experience in EDC systems set-up is required
  • SAS programming knowledge and experience is useful
  • CDISC standards knowledge is beneficial for the position
  • Excellent organizational and communication skills


  • Bachelor’s Degree, B.S. preferred


  • Strong computer and analytical skills
  • Good written and verbal communication skills
  • Fluent in English
  • Ability to set priorities and respect tight deadlines
  • Problem solving skills, team player