Clinical Development Advisor

hace 1 semana


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

Overview

At PSI CRO, we are seeking a highly skilled Clinical Development Advisor to join our team. As a key member of our Medical Monitoring team, you will provide medical input to global clinical studies and collaborate with internal departments to prepare clinical development plans.

About the Role

This is an exciting opportunity for a medical professional to work on the frontline of medical science, providing medical expertise to support the development of new medications. The successful candidate will have extensive experience in medical practice/patient care and a strong background in clinical trials.

Responsibilities

  • Medical Input and Collaboration
    • Provide medical input to global clinical studies and advise teams and business partners 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
  • Data Review and Analysis
    • 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
  • Study Oversight and Compliance
    • 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
  • 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 Spanish
    • Proficiency with MS Office applications
    • Communication, presentation and analytical skills
    • Problem-solving, team and detail-oriented


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