ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life... and revisions. Performs and completes quality review and verification vs source data. Completes project/workstream/ClinChoice...
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 St...
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 St...
Primary Responsibilities: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & complia...
Responsibilities: Safety Management & Reporting Perform regulatory monitoring for impact on vigilance activities and responsibilities. Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeho...
Primary Responsibilities: Perform Intake/Triage, Data Entry, and Quality Review for individual case safety reports from a variety of sources, including spontaneous, literature, regulatory, and clinical trial cases. Manage case finalization ...