Medical Monitor Hematology H/F - PSI CRO

PSI is a leading Contract Research Organization with more than 25years 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 Monitorsprovide 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 analyzeclinical 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 ofHematology
- Full working proficiency in English
- Proficiency with MS Office applications
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented