Senior Medical Reviewer ensuring patient safety and high-quality data in clinical trials at Novo Nordisk's Bengaluru location. Collaborating with medical specialists and conducting medical reviews.
Responsibilities
Perform Medical Review of all trial subjects of assigned clinical trials
Ensure patient safety and adherence to protocols, GCP, ICH Guidelines
Collaborate with study group members during trial conduct
Report status of medical review to project as appropriate
Consult with Trial Managers and Medical Specialists
Contribute to trial planning activities related to medical review
Resolve issues of medical concern in clinical trial data
Document medical review in the sponsor TMF
Review and provide inputs to medical monitoring displays
Requirements
A graduate degree in MBBS+MD
2 to 5 years of experience
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.
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