Senior Medical Reviewer

• 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 Good 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 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:

• A graduate degree in Medicine or a related field is required (MBBS MD in Pharmacology preferred; MBBS MD in other clinical or paraclinical areas with relevant experience in clinical patient management or clinical research will also be considered)
• Preferably 3-5 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, Scientific Clinical Drug Development etc)
• 1-2 years of project management experience is essential
• Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice) principles
• Proficient in computer applications, including MS Office, MS Project, and PowerPoint
• Strong grasp of medical terminology and clinical trial processes
• Demonstrated analytical skills with a results-oriented approach
• Exceptional proficiency in written and spoken English