Medical Monitor (Hematology)

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

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

Responsibilities: 

• 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, clinical study reports
• Review and sign off clinical documents with respect to medical relevance
• Review and analyze clinical data including safety monitoring
• Perform medical review of 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 the project teams and sites
•  Participate in BID defense, Kick-off meetings, Investigator's Meetings (prepare and deliver presentations)
• Participate in project risk assessment activities, identify program risks, and create and implement mitigation strategies with Clinical Operations

• 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 of and experience in the area of Hematology
• Full working proficiency in English
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.