Company description
psi is a leading contract research organization with more than 25 years 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 monitors *provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.
only cv's in english will be considered
*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
- 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
- review and sign off clinical documents with respect to medical relevance.
*qualifications*:
- medical doctor degree
- oncology fellowship certification is a must
- prior and wide experience as a practicing oncologist (minimum of 10 years)
- full working proficiency in english and spanish
- 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.