Medical Monitor, Certified Oncologist

PSI CRO AG; São Paulo; Teletrabalho; BRL 150.000 - 200.000; Tempo integral

Resumo da oferta

A leading Contract Research Organization is seeking a Medical Monitor to provide medical input to global clinical studies. This role involves advising teams on medical matters, ensuring participant safety, and compliance with regulatory guidelines. Join a team of international medical professionals and contribute to bringing new medications to patients.

Qualificações

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

Responsabilidades

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

Conhecimentos

Communication

Problem-solving

Analytical skills

Formação académica

Oncology Fellowship certification

Ferramentas

MS Office

Descrição da oferta de emprego

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 Brazil

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 Portuguese
• 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.