Job Description

Job Overview

Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective.

Essential Functions

  • Interprets the study protocol.
  • Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable.
  • Create and update Edit Specification Document.
  • Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page)
  • Complete the Study Authorization Form and Trial Capacity Request Form (InForm)
  • Attend the Pre-Design Meeting,...

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