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.
About the role
- Senior Medical Reviewer at Novo Nordisk ensuring quality and compliance in clinical trials. Collaborating with a skilled team focused on patient safety and data integrity in drug development.
Responsibilities
- Conducting medical reviews of clinical trial data to ensure patient safety, protocol compliance, and adherence to regulatory requirements
- Collaborating closely with study group members, including Data Managers, Trial Managers, and Medical Specialists
- Identifying and resolving issues of medical concern and inconsistencies in clinical trial data
- Presenting findings of medical reviews to relevant Medical Specialists
- Documenting medical reviews in the sponsor Trial Master File (TMF)
- Performing quality control of medical review tasks and findings
- Providing training and mentoring to new team members
- Contributing to shared best practices, process improvements, and other activities
- Planning and managing resources for medical review tasks
Requirements
- A graduate degree in MBBS+MD with 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
Benefits
- Professional development opportunities
- Flexible working hours
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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