Description
We are looking for a
CRO Manager – Data Management and Statistics (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Clinical data manager
Keywords: Clinical Data Manager