Analyste de systèmes cliniques
Core
Support the implementation and maintenance of clinical trial systems for a biotech company developing antibody-based drugs.
Role type
Clinical Systems Analyst (Business Operations)
Builds
Clinical trial systems (RTSM, EDC, eCOA) for drug development programs
Domain
Biotechnology / Clinical Trials / Healthcare IT
Required skills
Clinical trial system knowledge (RTSM, EDC, eCOA), GxP regulations, test script execution, stakeholder communication, problem-solving, documentation
Preferred skills
Canadian clinical trial regulations (Health Canada), French language proficiency
Technologies
RTSM, EDC, eCOA
Responsibilities
Provide training and daily support to clinical system users; Write and execute validation test scripts; Work with vendors on configuration changes and upgrades; Participate in change management for protocol amendments; Identify system issues and determine corrective actions; Translate stakeholder feedback into configuration adjustments.
Seniority
Mid-Senior level (5+ years experience)