Medical Monitor (Gastroenterology)
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Job Location:
Saint-Maur-des-Fossés - France
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
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:
- Serve as 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 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 patient narratives and scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical trials
- Ensure that the reported trial 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 trial from sites and the study team
- Provide support for medical data review
- Participate in bid defense meetings and proposal activities
- Assist in Pharmacovigilance activities
- Identify trial risks and create and implement mitigation strategies with other relevant departments
- 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
- Gastroenterology Fellowship certification is a must
- Prior experience as a practicing MD (minimum of 10 years)
- Prior research and/or industry experience is a plus
- Full working proficiency in English
- Proficiency with MS Office applications
- Communication presentation and analytical skills
- Able to work in teams problem-solving and detail-oriented
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.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Environmental Safety
- Fashion Retail
- C++
- Arabic Faculty
- BI
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
