Associate Medical Reviewer
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Bangalore • 🇮🇳 India
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Conduct medical review of all trial subjects in assigned clinical trials to ensure high-quality, consistent medical data.
- Ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations, and SOPs.
- Identify and resolve issues of medical concern or inconsistencies in clinical trial data by collaborating with investigational site staff and healthcare professionals.
- Present findings from medical reviews to relevant Medical Specialists to enable informed decision-making.
- Perform medical monitoring tasks, including protocol compliance checks, identifying clinically significant outliers, and ensuring data consistency.
- Document all medical review activities to always ensure inspection readiness.
- Stay updated on therapeutic knowledge, protocol-specific guidelines, and the latest medical developments.
- Collaborate closely with trial teams, including Data Managers, Trial Managers, and Medical Specialists, to ensure quality deliverables.
Requirements
- A graduate degree in MBBS+MD
- 1-2 years of experience in clinical practice or academics
- Good knowledge of ICH GCP guidelines.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint)
- Excellent understanding of medical terminology and clinical trial activities
- Experience with risk-based monitoring methodologies.
- Familiarity with clinical trial data systems and tools.
- Excellent written and spoken English
- Strong analytical and result-oriented skills
- Ability to plan and handle complex tasks independently
- Good communication and stakeholder management skills
Benefits
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical reviewclinical trial data analysisprotocol compliance checksrisk-based monitoring methodologiesmedical monitoringdata consistency checksmedical terminologyclinical practiceanalytical skillsresult-oriented skills
Soft skills
communication skillsstakeholder managementcollaborationindependent planningproblem-solving
Certifications
MBBSMDGood Clinical Practice (GCP)