Medical Monitor

Summary

Join PSI, a leading Contract Research Organization, as a Medical Monitor and contribute to global clinical studies. Based in the US, you will advise clients and teams on medical matters, ensuring patient safety and data accuracy. Responsibilities include reviewing clinical data, addressing safety issues, and collaborating on study documents. This role requires a Medical Doctor degree, US Board Certification in Nephrology, and at least 10 years of Nephrology experience. You will work with international medical professionals, advancing medical science and contributing to new medication development.

Requirements

• Medical Doctor degree required
• US Board Certification in Nephrology required
• Experience as a practicing Nephrology (minimum of 10 years)
• Full working proficiency in English

Responsibilities

• 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, manuscripts, and different scientific presentations
• Review and analysis of 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
• Review listings for coded events to verify Medical Dictionary for Regulatory activities
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to 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 documents with respect to medical relevance

Preferred Qualifications

• Clinical Research experience preferred
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented