Clinical Systems Analyst
Core
Provide hands-on support for clinical trial system implementations and sustainment, acting as a liaison between Clinical Operations, Digital Quality, and IT.
Role type
Clinical Systems Analyst
Builds
Clinical trial systems (RTSM, EDC, eCOA) for antibody-based medicine development
Domain
Biotechnology / Clinical Trials
Required skills
Clinical trial systems (RTSM, EDC, eCOA), ICH-GCP guidelines, Health Canada regulations, validation test scripts, vendor coordination, change management, issue analysis, documentation
Preferred skills
Bilingualism (English and French), Life Sciences degree, pharmaceutical/biotech/CRO experience
Technologies
RTSM, EDC, eCOA
Responsibilities
Provide day-to-day user training, support, and troubleshooting; Create and execute validation test scripts; Coordinate with vendors on configuration changes and upgrades; Support change and release activities; Identify and analyze system issues and trends; Translate stakeholder roadblocks into actionable configuration changes
Seniority
Mid-level, hands-on IC