About the role
Career Category
ClinicalJob Description
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.
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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
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
Skills & Tags
Aplyr's read
Amgen is a biotechnology leader focused on innovative therapeutics in oncology, cardiovascular, and inflammation, attracting professionals in science, engineering, and data analytics.
What's promising
- •Strong focus on cutting-edge biotechnology and human therapeutics.
- •Diverse career opportunities in scientific, engineering, and data roles.
- •Commitment to addressing serious health conditions like cancer and cardiovascular disease.
What to watch
- •Highly competitive industry with constant innovation demands.
- •Regulatory challenges in developing and marketing new therapies.
- •Potential for high-pressure work environment due to ambitious goals.
Why Amgen
- •Pioneering in biologic therapies with a focus on serious diseases.
- •Robust pipeline of innovative drugs in various therapeutic areas.
- •Global presence with a strong emphasis on research and development.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Amgen
AMGN$354.06+4.84%
Amgen is a leading biotechnology company that discovers, develops, manufactures, and delivers innovative human therapeutics. The company focuses on areas such as oncology, cardiovascular disease, and inflammation.
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