Medical Monitor, Certified Radio-Oncologist

PSI CRO; Ciudad de México; A distancia; MXN 800,000 - 1,200,000; Jornada completa

Descripción de la vacante

A leading Contract Research Organization is seeking a Medical Monitor based in Mexico. The role involves providing medical input to global clinical studies, ensuring patient safety, and collaborating with various teams. Candidates must have an Oncology Fellowship and extensive experience as an Oncologist. Proficiency in English and Spanish is required.

Formación

• Minimum of 10 years experience as a practicing Oncologist.
• Full working proficiency in English and Spanish.

Responsabilidades

• Advise clients and project teams on medical matters.
• Review and analyze clinical data for participant safety.
• Ensure compliance with FDA, EMEA, ICH and GCP guidelines.

Conocimientos

Communication

Problem-solving

Analytical skills

Presentation

Educación

Oncology Fellowship certification

Herramientas

MS Office

Descripción del empleo

PSI is a leading Contract Research Organization with more than 25years 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 Monitorsprovide 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
• 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

• Oncology Fellowship certification is a must
• Prior and wide experience as a practicing Oncologist (minimum of 10years)
• Full working proficiency in English and Spanish
• Proficiency with MS Office applications
• 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.