Consultant Global Clinical Data Sciences (d/m/w) – Freelance – on hold

  • Position zu besetzen ab 16. Mai 2021
  • Permanent-ID OCR-FL-1299
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Tasks

  • Support Merck in ensuring consistency of SDTM conversion deliverables (including SDTM aCRF, datasets, define.xml, reviewers guide etc.) against Merck Standard specifications
  • Ensure cross-Project consistency and harmonization of SDTM settings and controlled terminologies within the respective project submission package
  • Review and comment SDTM-conformant CRF annotations, SDTM mapping proposals, SDTM conversions deliverables including define.xml
  • Track and follow up on QC check findings with external partners in review cycles until resolution

 

Requirements

  • Excellent CDISC-SDTM expertise
  • Very good SDTM-knowledge on oncology specifics
  • Comprehensive knowledge of FDA/PMDA regulations
  • Very good communication skills

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