Neurology Medical Monitor

Summary

Join MMS, an award-winning, data-focused CRO, and be part of a supportive, innovative team. This project-based consulting opportunity focuses on medical monitoring on an as-needed basis. Responsibilities include eligibility review, safety data review, developing medical monitoring plans, participating in safety review meetings, medical query management, and medical coding review. The role requires maintaining records, reviewing study documents, and providing medical input throughout the development process. You will lead safety activities, develop risk management strategies, and stay updated on pharmacovigilance trends and regulations. This is not a full-time position.

Requirements

• Medical degree required (MD or equivalent)
• Specialty in Neurology or comparable experience in Neurology
• 5 or more years of clinical experience and/ or research experience required
• Relevant experience in medical monitoring and/or medical reviewer in pharmaceutical industry
• Excellent scientific writing skills
• Ability to understand clinical data
• Proficiency with MS Office applications
• Good communication skills
• Strong knowledge of current regulatory practices and domestic and international regulations

Responsibilities

• Responsible for medical monitoring tasks, which may include
• Eligibility review
• Review of safety-related protocol‑related deviations
• Review of safety data
• Develop Medical Monitor Plan
• Participation in medical monitoring and/or safety review meetings as needed
• Medical management of queries
• Medical coding review
• Maintain records and logs
• Medical review of study documents
• Provide medical input throughout the development process
• Provide medical input into the development and execution of study documents and plans, such as study protocol, IB, SMP, DMP, SAP, Lab manuals, etc
• Provide significant expertise as primary medical reviewer of individual adverse event reports, clinical, and safety documents
• Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company
• Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations
• Responsible for strategies in monitoring and analysis of cumulative safety information
• Maintains significant knowledge of global and local regulations and guidance as they pertain to medical review and safety reporting