Trial Data Manager Phase 1 (m/w)

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Location Baden-Württemberg, Deutschland Salary Verhandelbar
Sector Life Sciences Type Contract

Main Requisites:

  • Systems to be used: RAVE, JReview, SAS
  • Language. Excellent in English, German is a plus

Project Expectations:

  • Defining set-up of trial specific modules in RAVE*
  • Testing of data entry screens (test data entry in RAVE*)
  • Annotation of Case Report Form
  • Creation and filing of standard documents into Trial Master File
  • Creation and resolution of queries: Perform data cleaning and consistency checks, implausible study data entered by the investigator need to be queried and corrected
  • Cross-checks of Lab printouts (source data) vs. CDR data (Clinical Data Repository)
  • Creation of status reports for the study team: Creation of disposition tables of subjects in the trial, outstanding queries report
  • Preparing and performing MQRMs (Medical and Quality Review Meetings)
  • SAE (Serious Adverse Event) reconciliation: in RAVE* database vs. drug safety database
  • Defining of study specific data transmission agreements and loading of external data to CDR
  • Check of study specific SDTM data

Is this position of interest to you?

In the case that it is, I can gladly be contacted under the following number +49 (0) 89 5519 7835 or by email Please send me your updated CV in word format when the interest arises.

Looking forward to your application and possibly a mutual collaboration.

Sthree Germany is acting as an Employment Business in relation to this vacancy.