Medical Monitor

Summary

Join PSI, a leading Contract Research Organization (CRO), as a Medical Monitor and contribute to global clinical studies. You will be the medical point of contact for various stakeholders, advising on medical matters related to clinical trials. Responsibilities include reviewing clinical data, ensuring participant safety, and collaborating with internal departments on study documentation. This hybrid or remote position in Hungary requires a Medical Doctor degree, Gastroenterology Fellowship certification, and at least 10 years of experience as a practicing MD. Prior clinical trial experience is a plus. As part of PSI's Medical Monitoring team, you'll build your career on the frontline of medical science, helping bring new medications to patients.

Requirements

• Hold a Medical Doctor degree
• Possess Gastroenterology Fellowship certification
• Have a minimum of 10 years of experience as a practicing MD
• Be fully proficient in English
• Be proficient in MS Office applications
• Demonstrate strong communication, presentation, and analytical skills
• Exhibit problem-solving, teamwork, and attention to detail

Responsibilities

• Serve as the medical point of contact for the internal project team, study sites, and study sponsor regarding medical aspects of clinical trials, adhering to protocols and GCP guidelines
• Provide guidance to clients, project teams, sites, data safety monitoring boards, regulatory agencies, and third-party vendors on medical issues
• Collaborate with internal departments in developing clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, narratives, and various scientific presentations
• Review and analyze clinical data to guarantee the safety of study participants
• Ensure reported data is accurate, complete, verifiable, and that trial conduct complies with the approved protocol/amendments
• Address safety concerns arising from sites and the study team
• Support and/or conduct medical data reviews of the operational clinical trial database
• Participate in meetings with clients and investigators
• Assist in pharmacovigilance activities
• Identify program risks, and develop and implement mitigation strategies with Clinical Operations
• Organize and lead clinical development advisory boards and safety monitoring boards
• Ensure the study team's compliance with FDA, EMEA, ICH, and GCP guidelines
• Review and approve clinically relevant documents

Preferred Qualifications

Have prior experience in clinical trials