About The Position
PSI Medical Monitors provide essential medical input to global clinical studies, offering expert advice to internal teams and business partners. The core focus of this role is to ensure patient safety and well-being throughout clinical trials. This is a full-time permanent employment opportunity based in the UK, where the successful candidate will join an international group of medical professionals, contributing to groundbreaking advancements in the pharmaceutical industry by helping to 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
Number of Employees
501-1,000 employees
