Medical Monitor
hace 1 mes
PSI is a leading Contract Research Organization with more than 25 years 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 DescriptionPSI 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 analyze 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.
- 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.
- Internal Medicine certification is a must.
- Prior and wide experience in medical practice/patient care (minimum of 10 years).
- Prior experience working with clinical trials is a plus.
- Prior experience with ICU is a plus.
- Full working proficiency in English and Spanish.
- Proficiency with MS Office applications.
- Communication, presentation, and analytical skills.
- Problem-solving, team, and detail-oriented.
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.
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