Medical Science Specialist

Há 2 dias


São Paulo, São Paulo, Brasil Psi Cro Ag Tempo inteiro
Medical Monitor

At PSI, we are seeking a highly skilled Medical Monitor to join our team of medical professionals. As a Medical Monitor, you will play a critical role in ensuring the safety and well-being of study participants in clinical studies.

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.
  • 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:
  • 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.

As a Medical Monitor at PSI, 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 who need them.



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