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 coverageAdvise clients, data safety monitoring boards, regulatory agencies and third-party vendors on medical mattersCollaborate with Project Management, Clinical Operations and other departments in the preparation of clinical development plans, protocols, investigator brochures, clinical study reportsReview and sign off clinical documents with respect to medical relevanceReview and analyze clinical data including safety monitoringPerform medical review of and follow up on incoming SAE reports including narrative content and queriesAddress safety issues across the study from sites and the study teamProvide 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

QualificationsMedical Doctor degreeBoard certified in HematologyExperience in medical practice/patient careExperience in a similar role is a plusKnowledge of the safety review process, medical terminology, coding dictionaries and safety regulatory requirements Strong knowledge of and experience in the area of HematologyFull working proficiency in EnglishProficiency with MS Office applicationsCommunication, presentation and analytical skillsProblem-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.