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In this vital role, the Senior Associate - Medical Data Reviewer is responsible for ensuring the clinical integrity, quality, and interpretability of data generated across the clinical development lifecycle. The role applies strong medical and scientific judgment to complex clinical datasets to safeguard patient safety, enable timely signal detection, and support regulatory-ready decision making. The position requires both clinical expertise and analytical rigor, with the ability to distinguish clinically meaningful signals from background variability and drive appropriate actions when required.
Job Responsibility
Conduct ongoing medical review of clinical trial data to ensure accuracy, consistency, and clinical relevance
Evaluate adverse events, laboratory data, vital signs, ECGs, imaging, and other key safety and efficacy endpoints
Identify trends, outliers, protocol deviations, and emerging safety signals across studies
Apply medical judgment to distinguish clinically meaningful findings from normal variability
Provide medical input into study start-up activities, including risk assessments and data review strategy
Partner cross-functionally with Clinical Operations, Data Management, Safety, Biostatistics, and vendors to resolve data issues
Contribute to the development and refinement of medical review tools, visualizations, and dashboards (e.g., Spotfire)
Lead or contribute to data review meetings, governance discussions, and issue escalation processes
Author and maintain clear, defensible medical documentation to support inspection readiness
Drive continuous improvement by identifying systemic data quality trends and strengthening review standards and workflows
Requirements
MBBS, MD, PharmD, BDS, BAMS, BHMS, or other relevant medical/healthcare degree with clinical research experience
Master’s degree in Life Sciences, Pharmacy, Public Health, or related field with 5+ years of clinical research experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline with 7+ years of clinical research experience
Nice to have
5+ years of experience in clinical research within biotech, pharmaceutical, or CRO environments