The Medical Monitor is responsible for providing medical oversight during the conduct of clinical studies (ranging from single-center to multi-center, multinational studies) managed by bioskin, the goal being to ensure the safety and clinical integrity of participating subjects/patients.
Principal Responsibilities and Duties:
• Ongoing review of laboratory and ECG alerts
• Medical expertise and guidance for project team and clinical sites regarding subject/patient eligibility and safety issues and any protocol-related medical questions during study conduct
• Safety review of AEs/SAEs
• Review of medical data listings including vital signs, concomitant medication, medical history, laboratory data, amongst other data
• Medical assessment of protocol deviations
• Participates in project team meetings and medical team meetings and serves as medical interface between sponsors and clinical site teams.