Beschreibung
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 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.