eCOA & RTSM Application Specialist-Canada
Core
Design, deploy, and configure electronic Clinical Outcome Assessment (eCOA) and Randomization and Trial Supply Management (RTSM) solutions for global clinical studies.
Role type
Clinical Data Management Specialist (eCOA/RTSM)
Builds
eCOA and RTSM system configurations and study deliverables
Domain
Clinical Research / eClinical
Required skills
eCOA system configuration, UAT test script creation, CDISC data mapping, regulatory compliance (ICH-GCP, FDA, EMA), study lifecycle management, vendor relationship management
Preferred skills
ePRO knowledge, patient-reported outcomes expertise, clinical trial process understanding
Technologies
eCOA platforms, RTSM systems, EDC systems
Responsibilities
Define functional requirements for eCOA/RTSM solutions, create UAT test scripts, validate eCOA logic against protocols, support CDISC-compliant data mapping, prepare study-specific training materials, document system configurations in Trial Master File, ensure compliance with regulatory standards
Seniority
Mid-level, hands-on IC
