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. Only CV's in English will be considered **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 - Oncology Fellowship certification is a must - Prior and wide experience as a practicing Oncologist (minimum of 10 years) - 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.