Medical Reviewer

Medical Reviewer

Are you passionate about ensuring patient safety and the integrity of clinical trial data? Do you have experience in medical review and a strong understanding of clinical trial activities? If yes, we invite you to join our Centralized Monitoring Unit (CMU) team in Bangalore as a Senior Medical Reviewer. Read on and apply today!

Position

Please note: This position involves providing medical oversight in clinical drug development. It is not a Pharmacovigilance role

The Key Responsibilities in this position will be to perform Medical Review of all trial subjects of all assigned clinical trials to ensure high 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 Procedure (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 status of medical review to 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 Specialist to enable decision making. Responsible for documenting medical review 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.

Qualifications

We are looking for a highly skilled and motivated individual who meets the following criteria:

• A graduate degree in MBBS+MD with 2 to 5 years of experience
• 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

About the department