Senior Medical Reviewer

Key Responsibilities

• Perform centralized medical review of clinical trial subject data
• Ensure compliance with ICH-GCP, SOPs, protocol and regulatory requirements
• Identify clinically significant data inconsistencies, trends and safety concerns
• Collaborate with Data Managers, Trial Managers and Medical Specialists
• Support trial planning activities related to medical review
• Review Medical Monitoring Plans (MMP), data listings and monitoring displays
• Present medical review findings for clinical decision-making
• Resolve medical queries with investigational sites
• Ensure medical review documentation is maintained in sponsor TMF
• Escalate critical medical issues in accordance with blinding and communication plans

Required Qualifications

• MBBS + MD
• 2–5 years of experience in Clinical Research / Medical Review
• Strong knowledge of ICH-GCP guidelines
• Experience in risk-based monitoring methodologies
• Familiarity with clinical trial data systems and tools
• Strong MS Office / PowerPoint / MS Project skills
• Excellent English communication and analytical skills
• Ability to manage complex, independent responsibilities

About the Department

The Centralized Monitoring Unit (CMU), Bengaluru, supports Novo Nordisk’s global clinical drug development programs. Medical Reviewers collaborate with international medical specialists to ensure protocol compliance, detect clinically significant outliers, maintain data quality, and safeguard participant safety through advanced risk-based monitoring frameworks.

Why Join Novo Nordisk

• Work on global clinical development programs
• Direct impact on patient safety and regulatory compliance
• Collaborative international exposure
• High career growth potential in Clinical Research & Medical Affairs