Associate Medical Reviewer

Novo Nordisk

1 - 2 years

2 - 6 Lacs

bengaluru

Posted:-1 days ago| Platform:

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Skills Required

medical mbbs data cleaning gcp stakeholder management clinical research compliance data systems clinical trials research healthcare

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Position

As an Associate Medical Reviewer, you will:

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.

Qualifications

We are looking for a candidate with the following qualifications:

Need to have:

A graduate degree in MBBS+MD with - 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

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