eCOA & RTSM Application Specialist-South Africa
Core
Support the design, deployment, configuration, and oversight of electronic Clinical Outcome Assessment (eCOA) and Randomization and Trial Supply Management (RTSM) solutions across global clinical studies.
Role type
Clinical Data Management Specialist (eCOA/RTSM)
Builds
eCOA and RTSM system configurations and study implementations
Domain
Clinical Research / eClinical
Required skills
eCOA systems expertise, ePRO knowledge, clinical trial processes, data management principles, system configuration, UAT, edit checks, validation, CDISC standards, regulatory compliance (ICH-GCP, FDA, EMA), data cleaning strategies, training material development, vendor management
Preferred skills
Computer Science or Life Sciences degree, global trial experience, digital mindset, problem-solving, stakeholder communication
Technologies
eCOA platforms, RTSM systems, EDC, IRT
Responsibilities
Define functional requirements and design eCOA/RTSM solutions, draft system specifications and user requirements, create UAT test scripts and coordinate validation, validate eCOA logic against protocols, support CDISC-compliant data mapping, contribute to data cleaning strategies, prepare study-specific training materials, document system configuration and file deliverables into TMF, manage updates and change requests, troubleshoot issues and escalate risks, ensure compliance with regulatory standards, contribute to SOPs and process improvements
Seniority
Mid-level, hands-on IC
