CRO Manager – Data Management and Statistics (m/f)

REFERENZNUMMER:

267414/11

IHRE AUFGABEN:

-Study set-up: Determine (CRO) provider for data management and statistics tasks; set up work orders; track payments and invoices; provide chosen CRO with client's standard guidelines for data management and statistics and planned timelines; coordinate CRF design
-Ongoing: Review and approve study specific procedures developed by CRO against client's standards and the protocol; review and approve study specific dataset structure provided by CRO; review study data with internal study team; review SAE reconciliation with the safety team; review and approve Statistical Analysis Plan (SAP)
-Database Lock: Review and approve final coding and Quality Control Report; receive and check final SAS datasets
-Review PK analysis plan: Coordinate development of the pharmacokinetics analysis between internal clinical pharmacologist and the CRO
-Filing/Archiving: Organise receipt of data and documentation for archiving; archive according to internal archiving procedures

IHRE QUALIFIKATIONEN:

-Good knowledge of contractor management and data management, covering all phases of studies
-Knowledge in SAS programming of study tables and listings
-Knowledge in development of SAP
-Knowledge in determining protocol deviations and analysis populations
-Knowledge in eCRF development and usage
-Good knowledge of SDTM and CDASH standards required
-Fluency in English (both written and verbal), knowledge of German is an advantage
-Ability to work responsibly without supervision
-Good written and verbal communication skills
-Good organisational skills, teamwork orientation, flexibility and integrity

WEITERE QUALIFIKATIONEN:

Clinical data manager