Real World Data Specialist
Core
Lead planning and execution of real-world data (RWD) collection within Expanded Access Programs (EAPs) and non-interventional studies to support drug development and patient access.
Role type
Real-World Data Specialist (Clinical Research Operations)
Builds
Real-world data sets for drug development programs and Expanded Access Programs
Domain
Healthcare / Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
RWD study planning and execution, EDC system familiarity, ICH-GCP compliance knowledge, data quality monitoring, SOP and template refinement, stakeholder coordination
Preferred skills
ICH-GCP certification, experience in clinical trial patient recruitment or EAP management
Technologies
Electronic Data Capture (EDC) systems, Microsoft Office Suite
Responsibilities
Lead RWD collection in EAPs and non-interventional studies; Monitor data completion and quality; Ensure regulatory compliance; Refine study processes and documentation; Collaborate with cross-functional teams
Seniority
Mid-level, hands-on IC
