Medical Monitor
Posted on 3/22/2023

51-200 employees

Clinical trial infrastructure company
Company Overview
Vial is on a mission to reimagine clinical trials and deliver faster and more efficient trials for sponsors. Through their end to end technology platform, Vial is delivering on a generational opportunity to make trials radically more efficient.
San Francisco, CA, USA
Experience Level
Medical, Clinical & Veterinary
  • Doctor of Medicine (MD) in Ophthalmology with retina specialty with a minimum of 5 years direct experience in the pharmaceutical industry, preferably in a medical monitoring role, required
  • Relevant work experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required
  • Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research
  • Work as primary Medical Monitor for assigned clinical trials which includes being readily available to advise on trial related medical questions or problems during the conduct of the trial
  • Review and analysis of eligibility per inclusion/exclusion requirements of a clinical trial
  • This may include assessment of diagnostic imaging per protocol requirements
  • Reviewing all adverse events to look for trends or risks, review all serious adverse events (SAEs), including review of the narrative, investigators' assessment on causality, and applicable regulatory reporting
  • Provide review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
  • Consult with internal and external stakeholders and experts to assist in the development and assisting in the design and conduct of clinical trials including the drafting of protocols and amendments
  • Assist with business development activities, including participation in bid defenses, and the development of business proposals as it pertains to Medical Affairs
  • Develop and/or review operational, medical monitoring, and safety plans for awarded studies
  • Assist in the study feasibility process by generating/reviewing feasibility questionnaires, identifying patient pathways, defining standard of care, and support site identification and selection
  • Lead and/or participate in scientific and medical training to other Vial team members and outside clients, investigators, and other site staff as it pertains to assigned studies
  • This may include travel, attendance, and presentation at investigator meetings, symposiums, and/or conferences
  • Monitor patient safety by acting as a medical monitor and/or in the development and conduct of a DSMB
  • Ensure activities related to SAEs are conducted in accordance with applicable SOP's and regulations
  • Generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete
  • Write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events
  • 24/7 emergency coverage for safety-related matters