Medical Monitor (Hematology)

Company Description

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.

Job Description

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

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

Additional Information

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. #J-18808-Ljbffr