Medical Monitor (Gastroenterology)

PSI CRO

About The Position

PSI is a leading Contract Research Organization with 30 years experience 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. 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. This is a full-time employment based in France. As part of PSI's Medical Monitoring team, you will join an 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.

Requirements

Medical Doctor degree
Gastroenterology Fellowship certification is a must
Prior experience as a practicing MD (minimum of 10 years)
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

Nice To Haves

Prior research and/or industry experience is a plus

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