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
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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