Real World-Data Specialist
Core
Collect, ensure quality, and manage compliance of Real-World Data (RWD) from Expanded Access Programs (EAPs) and non-interventional studies to support patient treatment access.
Role type
Real-World Data Specialist
Builds
RWD datasets for drug development and treatment access programs
Domain
Healthcare / Clinical Research / Real-World Evidence
Deliverable
client delivery
Required skills
RWD collection, EAP management, ICH-GCP compliance, SOP development, data quality monitoring, stakeholder communication
Preferred skills
ICH-GCP certification, EDC system familiarity
Technologies
EDC systems, Microsoft Office Suite
Responsibilities
Lead planning and execution of RWD collection within EAPs and non-interventional studies; Manage communications with clients, physicians, and site staff; Monitor data quality and address discrepancies; Ensure compliance with ICH-GCP and regulatory guidelines; Refine and maintain SOPs and documentation; Collaborate with cross-functional teams to align deliverables with program goals
Seniority
Mid-level, hands-on specialist
