Clinical Development Physician

hace 1 semana


Ciudad de México, Ciudad de México PSI CRO A tiempo completo

Company Overview:

PSI CRO is a leading Contract Research Organization with over two and a half decades of experience in the industry, providing a perfect balance between stability and innovation for both clients and employees. We focus on delivering high-quality services on time across various therapeutic areas.

Job Description:

A Medical Science Consultant at PSI CRO will provide medical input to global clinical studies and advise teams and business partners while prioritizing patients' safety and well-being. The role is 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 preparing clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations.
  • Review and analyze clinical data to ensure the safety of study participants in clinical studies.
  • Ensure reported data accuracy, completeness, and verifiability, as well as compliance with approved protocols/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 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 regarding medical relevance.

Qualifications:

  • Internal Medicine certification is mandatory.
  • Prior and extensive experience in medical practice/patient care (minimum 10 years).
  • Prior experience working with clinical trials is advantageous.
  • Prior experience with ICU is advantageous.
  • Full proficiency in English and Spanish.
  • Proficiency with MS Office applications.
  • Excellent communication, presentation, and analytical skills.
  • Strong problem-solving, teamwork, and attention to detail.

Estimated Salary: $120,000 - $180,000 per annum based on location and experience.



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