Full-Time Medical Monitor, Certified Oncologist
PSI CRO is hiring a remote Full-Time Medical Monitor, Certified Oncologist. The career level for this job opening is Experienced and is accepting Mexico City, Mexico based applicants remotely. Read complete job description before applying.
PSI CRO
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Job Details
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
- Oncology Fellowship certification is a must
- Prior and wide experience as a practicing Oncologist (minimum of 10 years)
- Full working proficiency in English and Spanish
- Proficiency with MS Office applications
Skills:
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented
Benefits:
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.