Location: Bangalore, Karnataka, IN
Responsibilities:
- 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 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. Provide training on the project and process to the new team members.
- 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.
Qualifications:
- Minimum as Graduate 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).
- 2-3 years of experience as a Medical Reviewer is preferred.
- 1-2 years of experience in project management is required.
- 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.
- Strong Analytical skills and result-oriented.
- Excellent written and spoken English.
Apply here: https://careers.novonordisk.com/job/Bangalore-Senior-Medical-Reviewer-Karn/1063600101/