Full-Time Medical Monitor, Radio-Oncologist

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, focusing on patient safety and well-being.

Home-Based in Argentina

1. Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies, and third-party vendors on medical matters.
2. Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations.
3. Review and analyze clinical data to ensure participant safety in clinical studies.
4. Ensure reported data accuracy, completeness, verifiability, and trial conduct compliance with the approved protocol/amendments.
5. Address safety issues across the study from sites and the study team.
6. Review listings for coded events to verify Medical Dictionary for Regulatory Activities.
7. Participate in bid defense meetings.
8. Assist in Pharmacovigilance activities.
9. Identify program risks, create, and implement mitigation strategies with Clinical Operations.
10. Organize and lead clinical development advisory boards and safety monitoring boards.
11. Ensure study team compliance with FDA, EMEA, ICH, and GCP guidelines.
12. Review and sign off clinical documents regarding medical relevance.

Qualifications:

• Medical Doctor degree
• Oncology Fellowship certification is a must
• Prior and wide experience as a practicing Oncologist (minimum 10 years)
• Full working proficiency in English and Spanish
• Proficiency with MS Office applications
• Communication, presentation, and analytical skills
• Problem-solving, team, and detail-oriented skills

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