Beschreibung
* Defining set-up of trial specific modules in RAVE* Testing of data entry screens
* Annotation of CRF (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
* Systems to be used: RAVE, JReview, SAS
* Excellent in English
Schlagwörter:
Ulm, Trial Management, SAS
Kontaktperson: Account Manager Elektrotechnik / IT Herr Sigrid Kremling
FERCHAU Engineering GmbH
Niederlassung Ulm
Lise-Meitner-Straße 14
89081 Ulm