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 and external teams. This full-time remote position in Lithuania requires a Medical Doctor degree, Gastroenterology Fellowship certification, and at least 10 years of experience as a practicing MD. Experience in clinical trials 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

• Possess a Medical Doctor degree
• Hold a Gastroenterology Fellowship certification
• Have prior experience as a practicing MD (minimum of 10 years)
• Have full working proficiency in English
• Be proficient with MS Office applications
• Demonstrate communication, presentation, and analytical skills
• Exhibit problem-solving, team, and detail-oriented skills

Responsibilities

• Serve as the medical point of contact for the 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, data safety monitoring boards, 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, narratives, and different scientific presentations
• Review and analyze clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported 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 study from sites and the study team
• Support and/or perform medical data review of the operational clinical trial database
• Participate in meetings with clients and Investigators
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
• Review and sign off clinical medically relevant documents

Preferred Qualifications

Have prior experience in clinical trials

Benefits

Full-time remote employment in Lithuania