Data manager (m/f/d) for clinical studies (at the department of clinical research)

Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg

Scope of work:

  • Set-up and implementation of questionnaires and databases for phase 2 to 4 clinical trials in close cooperation with the project team:
    • Independent development, programming, review and validation of databases for clinical studies
    • Programming of automated edit checks
    • Programming of user interface for the clinical research associate
    • Database maintenance and query management
    • Database cleaning and database lock
  • Preparation of study specific documents (e.g. data management plan)
  • User support by trainings, preparation of eCRF completion guidelines and technical support throughout the study
  • Preparation and electronic transfer of data, e.g. for interim analyses
  • Statistical evaluation of data from clinical studies
  • Administration and further development of the area “data management” including QM requirements for the department (preparation of SOPs etc.)
  • Participation in the quality assurance of the EDC systems used
  • Collaboration with international partners

The majority of the above listed is to be implemented in English language.

Your profile:

  • Motivated and flexible
  • Completed university degree in medical documentation or comparable field, or completed training in data management
  • Relevant professional experience (at least 2 years) in the field of data management / database development of regulatory clinical studies required
  • Very good spoken and written English and German skills required, further language skills (ideally French) an advantage
  • Experience in creating electronic case report forms for clinical study databases (preferably in REDCapTM)
  • Ability and interest to familiarize yourself with new IT systems and areas of responsibility
  • Good knowledge of statistics and interest in medical questions
  • Experience in coding of clinical data with tools such as MedDRA and WHODrug Dictionary is an asset
  • Good programming skills ideally in R, Stata and SQL is an advantage
  • Knowledge of Good Clinical Data Management Practice is an advantage
  • GCP and AMG knowledge is an advantage
  • Knowledge of current standards and terminologies e.g. CDISC, GAMPS is an asset
  • Open-mindedness and communication skills, also in an intercultural team
  • A high degree of reliability, accuracy, team spirit, organizational skills and a sense of responsibility
  • Enjoy working independently

Our benefits:

  • A fixed-term contract for 2 years full-time with the option of continued employment. The position is generally suitable for part-time work.
  • Remuneration according to TV-AVH (comparable to TVöD)
  • An interesting and varied job in a modern research facility
  • Integration in an open-minded, motivated, international team
  • A central location at the Landungsbrücken, which is easily accessible by public transport
  • 30 days holidays per year
  • Flexible and family-friendly working hours
  • Childcare allowance
  • Subsidy for HVV-Profi Ticket
  • Company pension
  • Opportunities for further education and training
  • Special conditions in selected sports and fitness clubs

We support our employees in achieving a work-life balance and promote the professional equality of women and men. We strive to assist women in their scientific career, increase the number of women in research and reduce under-representation in all areas and positions in general. Applicants with disabilities will be given preference when equally qualified.

Please send your application with the usual documents (cover letter, detailed CV, certificates) by 31.12.2020 preferably in electronic form via our application form: https://jobs.bnitm.de/Data-manager-mfd-for-clinical-studies-eng-f109.html

If you have any questions regarding the application process or the selection procedure, please contact Anja Göttsche from the Human Resources Department (goettsche(at)bnitm.de).

For further questions about the advertised position, Dr. Mirjam Groger (groger(at)bnitm.de, phone 040/42818-480) will be at your disposal.