Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and
Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. Develop Tables,
Job Overview Provide comprehensive clinical lab data expertise as part of a team to develop and maintain Laboratory Data Management (LDM) tasks for the studies awarded to IQVIA Laboratories and meets the external client data reporting needs. May
Job Overview Serve as the liaison between Records Management and user departments regarding Trial Master files. Apply clinical research Records Management expertise to provide project related assistance across multiple project(s), sites, and project teams. Ensure all work
Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS; Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan; Develop Tables, Listings,