Medical Monitor Gastroenterology
Medical Monitor Gastroenterology
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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 wellbeing.
Hybrid work in Warsaw
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 thirdparty 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
- Gastroenterology Fellowship certification is a must
- Prior experience as a practicing MD (minimum of 10 years)
- Prior experience in clinical trials is a plus
- Full working proficiency in English and Polish
- Proficiency with MS Office applications
- Communication presentation and analytical skills
- Problemsolving team and detailoriented
Additional Information :
As part of PSIs 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
