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.
Responsibilities:
* Medical point of contact for internal project team, study sites and study sponsor for medical matters related to the conduct of clinical trials per protocol and per GCP guidelines
* 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, narratives, 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
* Supports and/or performs medical data review of the operational clinical trial database
* Participate in meetings with clients and Investigators
* Assist in Pharmacovigilance activities
* Identify Program risks, and create and implement mitigation strategies with Clinical Operations
* 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 medically relevant documents.
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
* 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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