Amazing Opportunity in Bangalore for Associate Medical Reviewer in Clinical Development – Medical Reviewer Jobs
The Centralised Monitoring Unit (CMU)- Bangalore is a department within the Clinical Drug Development area. It consists of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). The Medical reviewers actively collaborate with medical specialists from Denmark to ensure overall patient safety and well-being in clinical trials. Their responsibilities include ensuring compliance with the protocol, identifying potential outliers requiring medical attention, and performing medical data cleaning. The Functional Programmers develop operational visualizations to support proactive centralized monitoring, and the Statistical Monitors detect unusual data patterns, errors, and potential lack of compliance or fraud across trials.
Job role: Associate Medical Reviewer
Category: Clinical Development and Medical
Location: Bangalore, Karnataka, IN
Key responsibilities: Medical Reviewer Jobs
- Performing medical reviews of all trial subjects in assigned clinical trials to ensure high-quality, consistent medical data.
- Ensuring patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations, and Standard Operating Procedures (SOPs) through medical review.
- Collaborating closely with relevant study group members, especially Data Managers, Trial Managers, and Medical Specialists during trial conduct.
- Reporting the status of medical review to the project following the communication and blinding plans.
- Consulting with Trial Managers and Medical Specialists to escalate medical review issues in a timely manner.
- Contributing to or participating in trial planning activities related to medical review.
- Resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites.
- Presenting findings of Medical Review to relevant Medical Specialists to enable decision-making.
- Documenting medical review in the sponsor TMF.
- Reviewing and providing inputs to MMP, Medical Monitoring, Displays, or other data listings required for efficient medical review.
- Postgraduate degree in Medicine or other relevant field (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 in MS Office, MS Project, and PowerPoint.
- Excellent understanding of medical terminology and clinical trial activities.
- Excellent written and spoken English.