Job Opening for MBBS & MD Graduates at Novo Nordisk – Associate Medical Reviewer Role – Apply Below
Job Role : Associate Medical Reviewer
Company : Novo Nordisk
Location : Bengaluru, Karnataka, India (On-site)
Job Opening for MBBS & MD Graduates at Novo Nordisk
About the Department:
- 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 well-being 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 detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials.
- The Key Responsibilities in this position will be to perform a Medical Review of all trial subjects of all assigned clinical trials to ensure high-quality quality consistent medical data.
- Medical Review is performed for all trial subjects to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations, and Standard Operating Procedures (SOPs).
- Medical Reviewer ensures high-quality medical data through medical review of clinical trial data. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialists during trial conduct.
- Report the status of the medical review to the project as appropriate, following the project communication plan and blinding plan.
- Consult with Trial Managers and Medical Specialists as appropriate to ensure medical review issues are escalated in a timely manner.
- Responsible for contribution to or participation in trial planning activities related to medical review.
- Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites.
- Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making.
- Responsible for documenting medical reviews in the sponsor TMF.
- Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct.
- Review and provide inputs to MMP as well as Medical Monitoring, Displays, or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review.
- Minimum as Postgraduate in Medicine or other relevant (MBBS & MD in pharmacology preferred, MBBS & MD in other clinical/paraclinical areas with relevant experience in clinical patient management/ clinical research).
- 1 year of experience as a Medical Reviewer is preferred.
- Good knowledge of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), and GCP (Good Clinical Practice).
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Excellent understanding of medical terminology and clinical trial activities.
- Excellent written and spoken English.