Clinical Review Specialist
Core
Review patient data and clinical study deliverables to ensure accuracy and compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) for pharmaceutical and biotech clients.
Role type
Clinical Review Specialist
Builds
Clinical data review deliverables and validated patient data sets
Domain
Pharmaceutical / Clinical Trials / Biotechnology
Required skills
Clinical data review, GCP compliance, SOP adherence, Data Validation Manual interpretation, Protocol understanding, Data issue identification, Cross-functional collaboration, Pharmaceutical/clinical terminology, Computer program proficiency
Preferred skills
None stated
Technologies
Interactive computer programs
Responsibilities
Review patient data in accordance with Data Validation Manuals, Identify and resolve data issues with study sites and teams, Ensure data review activities meet quality, budget, and timeline expectations, Provide guidance on clinical data review to project teams
Seniority
Mid-level, hands-on IC
