Associate Medical Reviewer
Company: Novo Nordisk
Location: Bengaluru
Department: Central Monitoring Unit (CMU), GBS Bengaluru
Functional Area: Clinical Development
Employment Type: Full-time, Regular
Application Deadline: 8 May 2026
Job Summary
The Associate Medical Reviewer role at Novo Nordisk focuses on medical review and centralized monitoring of clinical trial data to ensure patient safety, protocol compliance, and data quality.
The role sits within the Central Monitoring Unit and combines clinical expertise, data review, and cross-functional collaboration with global medical and operational teams, including Medical Specialists in Denmark.
Key Responsibilities
1. Medical Review of Clinical Trial Data
Conduct medical review of all assigned clinical trial subjects.
Ensure:
Data consistency
Medical accuracy
Protocol adherence
GCP and ICH guideline compliance
Identify clinically significant:
Outliers
Data inconsistencies
Safety concerns
2. Patient Safety & Protocol Compliance
Ensure patient safety throughout clinical trials.
Detect and escalate:
Medical issues
Safety concerns
Protocol deviations
Work closely with investigators and site staff to resolve issues.
3. Centralized Monitoring Activities
Perform medical monitoring tasks including:
Risk-based monitoring support
Data quality evaluation
Identification of abnormal trends in clinical data
Support inspection readiness by ensuring proper documentation.
4. Cross-functional Collaboration
Work closely with:
Data Managers
Trial Managers
Medical Specialists
Site investigators
Global teams (including Denmark-based stakeholders)
Present medical findings to support decision-making.
5. Documentation & Compliance
Document all medical review activities accurately.
Ensure audit readiness at all times.
Follow SOPs and regulatory requirements.
6. Therapeutic & Clinical Knowledge Maintenance
Stay updated on:
Protocol-specific requirements
Therapeutic area knowledge
Clinical research developments
Apply clinical knowledge in trial review and monitoring activities.
Required Qualifications
Education & Experience
MBBS + MD (mandatory requirement stated)
1–2 years of experience in:
Clinical practice OR
Academic medicine
Required Skills
Clinical & Regulatory Expertise
Strong understanding of:
ICH-GCP guidelines
Clinical trial processes
Medical terminology
Protocol compliance
Technical Skills
Proficiency in:
MS Office (Excel, PowerPoint, Word)
Clinical trial data systems
Basic clinical analytics tools
Analytical & Communication Skills
Strong ability to:
Analyze clinical data
Identify outliers and inconsistencies
Communicate findings clearly
Strong written and verbal English communication.
Behavioral Competencies
Independent task handling ability
Strong stakeholder management skills
Attention to detail
Ability to work in a global, matrix environment
Strong result orientation
Core Responsibilities Summary (Simple Version)
This role mainly involves:
Reviewing clinical trial patient data
Ensuring safety and protocol compliance
Detecting and fixing data issues
Supporting centralized monitoring teams
Working with global clinical stakeholders
Maintaining audit-ready documentation
Key Skill Areas
Clinical trial medical review
Patient safety monitoring
ICH-GCP compliance
Risk-based centralized monitoring
Clinical data interpretation
Cross-functional collaboration
Regulatory documentation discipline
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Japan | Saitama |Tokyo :
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