Psi is a leading contract research organization with more than 25years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
job description
psi medical monitorsprovide 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 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 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
* oncology fellowship certification is a must
* prior and wide experience as a practicing oncologist (minimum of 10years)
* full working proficiency in english and spanish
* 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.
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