Senior Medical Reviewer

4 weeks ago

bangalore, India Novo Nordisk AS Full time

Department – Centralised Monitoring Unit (CMU)

Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.

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 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 Position: (Note: This is not a role within Pharmacovigilance)

The Key Responsibilities in this position will be to perform a Medical Review of all trial subjects of all assigned clinical trials within the drug development portfolio across therapy areas & 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). Senior 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. 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.

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