16 Aug
|
Novo Nordisk
|
Bengaluru
16 Aug
Novo Nordisk
Bengaluru
- The Centralised Monitoring Unit (CMU)Bangalore, is a department within the Clinical Drug Development area
- It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors)
- Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning
- The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials
- The Senior Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio
- This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Positive Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs)
- Key responsibilities include collaborating closely with study team memberssuch as Data Managers, Trial Managers, and Medical Specialiststhroughout the trial process, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance
- Responsible for contribution to or participation in trial planning activities related to medical review
- Perform the quality check measure for the medical review
- Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational
📌 Senior Medical Reviewer (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru