Medical Monitor

Summary

Join PSI, a leading Contract Research Organization, as a Medical Monitor and contribute to global clinical studies. Based in the US, you will advise clients and teams on medical matters, ensuring patient safety and data accuracy. Collaborate on clinical development plans and reports, review clinical data, and address safety issues. Your expertise will help bring new medications to patients. This role requires a Medical Doctor degree, US Board Certification in Hematology, and significant experience as a practicing Hematologist and in clinical research.

Requirements

• Medical Doctor degree required
• US Board Certification in Hematology required
• Experience as a practicing Hematologist (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