Job Description
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 Brazil
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
* 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 Portuguese
* Proficiency with MS Office applications
* Communication, presentation and analytical skills
* Problem-solving, team and detail-oriented
Additional Information
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.