**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.Home-Based in Mexico**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.
