Medical Science Advisor

hace 3 semanas


Ciudad de México, Ciudad de México PSI CRO A tiempo completo
Medical Monitor Job Description

At PSI CRO, 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 providing medical input to global clinical studies and advising our teams and business partners on medical matters.

Key Responsibilities:
  • Medical Input and Advice: Provide medical input to global clinical studies and advise our teams and business partners on medical matters.
  • Clinical Development Planning: Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations.
  • Data Review and Analysis: Review and analysis of clinical data to ensure the safety of study participants in clinical studies.
  • Regulatory Compliance: 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.
  • Safety Issue Resolution: Address safety issues across the study from sites and the study team.
  • Medical Dictionary Review: Review listings for coded events to verify Medical Dictionary for Regulatory activities.
  • Pharmacovigilance Activities: Assist in Pharmacovigilance activities.
  • Program Risk Management: Identify Program risks, and create and implement mitigation strategies with Clinical Operations.
  • Advisory Board Participation: Participate in bid defense meetings and lead clinical development advisory boards and safety monitoring boards.
  • Regulatory Guidelines: Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines.
Qualifications:
  • Medical Degree: Medical Doctor degree.
  • Certification: Internal Medicine certification is a must.
  • Experience: Prior and wide experience in medical practice/patient care (minimum of 10 years).
  • Clinical Trials Experience: Prior experience working with clinical trials is a plus.
  • ICU Experience: Prior experience with ICU is a plus.
  • Language Proficiency: Full working proficiency in English and Spanish.
  • MS Office Proficiency: Proficiency with MS Office applications.
  • Communication Skills: Communication, presentation and analytical skills.
  • Problem-Solving Skills: Problem-solving, team and detail-oriented.

As a Medical Monitor at PSI CRO, 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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