• Ventura, CA, United States
AAAS Pearl River, NY, USA
ROLE SUMMARY * The clinician medical monitor may contribute towards providing medical and scientific expertise and oversight for Clinical Trials. * The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. ROLE RESPONSIBILITIES Accountable for safety across the study: * Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. * Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP. The...