Medical Expert for Clinical Studies
Há 1 mês
Company Overview
PSI CRO Ag is a leading Contract Research Organization with over 25 years of experience in the industry. We offer a perfect balance between stability and innovation to both clients and employees.
We focus on delivering quality and on-time services across various therapeutic indications.
Job Summary
As a Medical Monitor, you will provide medical input to global clinical studies and advise teams and business partners on medical matters.
You will work closely with internal departments to prepare clinical development plans, protocols, investigator brochures, annual reports, and other clinical documents.
Main 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.
Requirements
You must have an Internal Medicine certification.
Prior experience in medical practice/patient care (minimum of 10 years) is required.
Prior experience working with clinical trials is a plus.
Prior experience with ICU is a plus.
You should have full working proficiency in English and Portuguese.
Proficiency with MS Office applications is expected.
Excellent communication, presentation, and analytical skills are essential.
Problem-solving, team-oriented, and detail-oriented mindset is required.
Estimated Salary
R$ 12,000 - R$ 20,000 per month, depending on experience.
About PSI CRO Ag
As part of our international group of medical professionals, you will build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients who need them.
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