Medical Monitor

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.

Home-Based in Mexico

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.

Requirements

• Medical Doctor degree
• Internal Medicine certification is a must
• Prior and wide experience in medical practice/patient care (minimum of 10 years)
• Prior experience working with clinical trials is a plus
• Prior experience with ICU is a plus
• Full working proficiency in English and Spanish
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented