At a Glance
- Tasks: Join a team of medical professionals to monitor clinical trials and ensure patient safety.
- Company: PSI, a leader in medical monitoring with a global presence.
- Benefits: Competitive salary, career growth, and the chance to impact patient care.
- Other info: Collaborative environment focused on innovation and patient well-being.
- Why this job: Make a difference in patients' lives by bringing new medications to market.
- Qualifications: Gastroenterology Fellowship certification and prior MD experience required.
The predicted salary is between 54000 - 66000 £ per year.
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. 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 analyze clinical data to ensure the safety of study participants.
- 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:
- Gastroenterology Fellowship certification is a must.
- Prior experience as a practicing MD.
- Prior research and/or clinical trial 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.
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.
Medical Monitor (Gastroenterology). employer: PSI
As a Remote Director of Business Development at our dynamic global company, you will thrive in a supportive work culture that prioritises employee well-being and professional growth. With a commitment to innovation in medical science, we offer unique opportunities for career advancement while fostering strong relationships with clients and partners. Join us in making a meaningful impact on lives across the UK, all while enjoying the flexibility of remote work.
