Medical Monitor, Certified Radio-Oncologist

Summary

Join PSI's Medical Monitoring team as a Medical Monitor based in Brazil, providing medical input to global clinical studies and advising teams and business partners. You will advise on medical matters, collaborate on clinical development plans and reports, review clinical data for participant safety, and ensure data accuracy and compliance. Responsibilities include addressing safety issues, reviewing coded events, participating in bid defense meetings, assisting with pharmacovigilance, identifying program risks, and leading advisory boards. You will ensure compliance with FDA, EMEA, ICH, and GCP guidelines and review and sign off on clinical documents. This role requires a Medical Doctor degree, Oncology Fellowship certification, and at least 10 years of experience as a practicing Oncologist.

Requirements

• 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 Portuguese
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

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