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Medical Monitor

hace 2 semanas

Buenos Aires, Argentina PSI CRO A tiempo completo

**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**:

- Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
- Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical studies
- Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
- Address safety issues across the study from sites and the study team
- Review listings for coded events to verify Medical Dictionary for Regulatory activities
- Participate in bid defense meetings
- Assist in Pharmacovigilance activities
- Identify Program risks, and create and implement mitigation strategies with Clinical Operations
- Ability to organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign off clinical documents with respect to medical relevance.

**Qualifications**
- Medical Doctor degree
- Internal Medicine certification is a must
- Prior and wide experience in medical practice/patient care (minimum of 10 years)
- Prior experience working with clinical trials is a plus
- Prior experience with ICU is a plus
- Full working proficiency in English and Spanish
- 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.