Medical Monitor

il y a 1 jour

Leuven, Belgique PSI CRO Temps plein

**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.

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
- Full working proficiency in English
- 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.

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