PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners while always focusing on patients safety and wellbeing.
Responsibilities:
- Provide medical monitoring to clinical project teams and sites including out of hours coverage
- Advise clients data safety monitoring boards regulatory agencies and thirdparty 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 Kickoff meetings Investigators 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
- Full working proficiency in English
- Proficiency with MS Office applications
- Communication presentation and analytical skills
- Problemsolving team and detailoriented
Additional Information :
As part of PSIs 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.
Remote Work :
Yes
Employment Type :
Fulltime