Senior Clinical Data & EDC Design Lead

IQVIA

Bellville

Sur place

ZAR 1 404 000 - 1 716 000

Plein temps

Il y a 3 jours
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Résumé du poste

IQVIA in South Africa seeks a Technical Designer to drive study build and eCRF design, ensuring alignment with SDTM/CDASH standards. You will collaborate with DTL, programmers, validation, vendors, statisticians, and client representatives to deliver projects and oversee programming-related financials.

The role involves designing the InForm-based database, creating edit specifications, and producing EDC component specs while leading internal design reviews and promoting continuous process

Qualifications

  • Interprets the study protocol and translates it into SDTM/CDASH-compliant eCRF design.
  • Design and update eCRF using CDMS tools per industry standards.
  • Create and update Edit Specification Document for study components.
  • Generate specifications for EDC build components such as Rights/Roles and System Settings.

Responsabilités

  • Lead and participate in design review meetings and present comments.
  • Design database to collect LLRR data and manage access rights.
  • Ensure project timelines and communicate risks to Data Team Lead.

Connaissances

eCRF design
CDMS tools
SDTM
CDASH

Formation

Bachelor's degree in Science/CS/IT

Outils

InForm

Description du poste

IQVIA in South Africa seeks a Technical Designer to drive study build and eCRF design, ensuring alignment with SDTM/CDASH standards. You will collaborate with DTL, programmers, validation, vendors, statisticians, and client representatives to deliver projects and oversee programming-related financials.

The role involves designing the InForm-based database, creating edit specifications, and producing EDC component specs while leading internal design reviews and promoting continuous process

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