**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, Online Screen Review Meeting, Unblinded Data review meeting. Att...