Senior Associate Medical Data Reviewer

Amgen Technology; Hyderabad; Presencial; INR 1 500 000 - 2 300 000; Tempo integral

Resumo da oferta

Amgen Technology in Hyderabad seeks a Senior Associate - Medical Data Reviewer to ensure clinical data integrity across development stages. You will apply medical judgment to interpret complex datasets and support safety, efficacy, and regulatory decisions.

The role requires collaboration with Clinical Operations, Data Management, Safety, and Biostatistics, with responsibility for data review tools, governance, and inspection readiness documentation.

Qualificações

• MBBS/MD/PharmD/BDS/BAMS/BHMS or related degree with clinical research experience.
• Masters degree in Life Sciences, Pharmacy, Public Health or related field with 5+ years of clinical research experience.
• Bachelors degree in Life Sciences, Pharmacy, Nursing or related discipline with 7+ years of clinical research experience.
• 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.

Responsabilidades

• 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.

Conhecimentos

Clinical data review

Medical judgment

Data interpretation

Cross-functional collaboration

Communication skills

Leadership in meetings

Formação académica

MBBS/MD/PharmD/BDS/BAMS/BHMS or related degree

Masters in Life Sciences/Pharmacy/Public Health

Bachelors in Life Sciences/Pharmacy/Nursing

Ferramentas

Spotfire

Power BI

Clinical data analysis tools

Descrição da oferta de emprego

Job Title - Senior Associate - Medical Data Reviewer

GCF - 4

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.

Minimum Requirements:

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