Senior Associate Medical Data Reviewer

Basic Qualifications:

• MBBS, MD, PharmD, BDS, BAMS, BHMS, or other relevant medical/healthcare degree with clinical research experience
• OR
• Master’s degree in Life Sciences, Pharmacy, Public Health, or related field with 5+ years of clinical research experience
• OR
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline with 7+ years of clinical research experience

Preferred Qualifications

• 5+ years of experience in clinical research within biotech, pharmaceutical, or CRO environments
• Experience reviewing large, complex clinical trial datasets
• Understanding of clinical data review processes and study conduct within GCP environments
• Experience with clinical data analysis or visualization tools (e.g., Spotfire, Power BI, or similar)
• Ability to interpret complex clinical datasets and translate findings into clear, actionable insights
• Strong written and verbal communication skills with experience presenting to cross-functional and leadership audiences

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Career Category

Clinical

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.

• 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.