Medical Monitor

Summary

Join PSI's Medical Monitoring team as a Medical Monitor, contributing medical input to global clinical studies and ensuring patient safety. Collaborate with various teams and stakeholders, including clients, project teams, and regulatory agencies. Review and analyze clinical data, ensuring accuracy and compliance with protocols and guidelines. Address safety issues, participate in bid defense meetings, and assist in pharmacovigilance activities. Lead clinical development and safety monitoring boards, and identify and mitigate program risks. This role requires a Medical Doctor degree, board certification in Neurology, and significant experience in Neurology and clinical research.

Requirements

• Medical Doctor degree required
• Board Certification in Neurology required
• Experience as a practicing Neurology (minimum of 10 years)
• Clinical Research experience required, such as experience as a Principal Investigator or Sub-Investigator
• Full working proficiency in English
• Proficiency with MS Office applications
• Excellent communication and presentation skills, comfortable public speaking
• Problem-solving, team and detail-oriented

Responsibilities

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Review listings for coded events to verify Medical Dictionary for Regulatory activities
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance