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In this vital role, the Senior Medical Data Reviewer is accountable for quality oversight of the Medical Data Reviewer (MDR) team across multiple Therapeutic Areas (TAs). This role is accountable for end-to-end clinical data review quality and delivery. The Senior Medical Data Reviewer provides people leadership to Medical Data Reviewers, serves as the point of escalation for complex clinical data issues, and partners cross-functionally to drive inspection readiness, compliance, and operational excellence.
Job Responsibility:
Directly manage and develop Medical Data Reviewers, establishing clear expectations, accountability, and performance standards
Build team capability through hiring, coaching, training, and succession planning
Oversee Medical Data Review & Signal Detection ensuring high-quality review of adverse events, labs, vitals, ECGs, imaging, and key endpoints. Identify trends, outliers, protocol deviations, and emerging safety signals
Serve as an escalation point for complex clinical data issues
providing expert clinical judgment to resolve complex or ambiguous data
Drive quality, compliance and risk management ensuring regulatory-ready documentation aligned with ICH-GCP, applying RBQM principles and leveraging KRIs/QTLs
Provide medical insight and strategic guidance to cross-functional partners to align data review outputs with study objectives and regulatory expectations
Strengthen and harmonize medical data review practices by advancing standardization, analytics adoption, and continuous process improvement