Full-Time Medical Monitor (Hematology)

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, focusing on patient safety and well-being.

• Provide medical monitoring to clinical project teams and sites, including out-of-hours coverage.
• Advise clients, data safety monitoring boards, regulatory agencies, and third-party vendors on medical matters.
• Collaborate with Project Management, Clinical Operations, and other departments in the preparation of clinical development plans, protocols, investigator brochures, and clinical study reports.
• Review and sign off clinical documents regarding medical relevance.
• Review and analyze clinical data, including safety monitoring.
• Perform medical review and follow-up on incoming SAE reports (including narrative content and queries).
• Address safety issues across the study from sites and the study team.
• Provide medical training to project teams and sites.
• Participate in BID defense, Kick-off meetings, and Investigator's Meetings (prepare and deliver presentations).
• Participate in project risk assessment activities, identify program risks, create and implement mitigation strategies with Clinical Operations.

Required Qualifications:

• Medical Doctor degree
• Board certified in Hematology
• Experience in medical practice/patient care
• Experience in a similar role is a plus
• Knowledge of the safety review process, medical terminology, coding dictionaries, and safety regulatory requirements.
• Strong knowledge and experience in Hematology
• Full working proficiency in English
• Proficiency with MS Office applications
• Communication, presentation, and analytical skills
• Problem-solving, team, and detail-oriented

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