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

Job type:
on-site
Start:
asap
Duration:
12 MM
From:
Hays AG
Place:
Basel
Date:
04/10/2015
Country:
flag_no Germany
project ID:
882885

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This project is archived and not active any more.
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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