Medical Monitor (Hematology/ Hemato-Oncology) Milano

Medical Monitor (Hematology/ Hemato-Oncology)
Milano
Lombardia, Milano

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/ Hemato-oncology is a plus

- 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/ Hemato-oncology

- 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.