· Medical guidance to site personnel and the project team regarding Protocol and other study-specific medical aspects· 24/7 medical consultancy support to investigators and project team· Monitoring of patient’s safety and well-being:o Detection of trends and outlierso Signal detectiono Eligibility checko Review of selected laboratory parameterso Protocol deviations review with proposed grading from medical/safety perspectiveo Review of subject discontinuation listo Monitoring of specific safety parameters (risks due to IMP or AxMP safety profile as wellas an indication)· Medical review/creation of case/narratives and participating in the SAE reconciliation as support to the Safety Department· Regular presentations of MM reports to the study team· Medical Review of patient data· Medical input to the study-related documents (including the preparation of the MM plan)· Participation in Kick-off Meetings, Investigator Meetings, and other study-related meetings,including participation at the safety committee meetings (DSMB, IDMC, and SRC meetings) andpresentation of the safety data· Training of the project team and investigators on the indication, IMP, AxMP, and other medical aspects of the study· Reviews or assists in the review of medical coding to assure congruency with the terms reported in the case report form (CRF) and provides re-coding of events if appropriate · Overview of SP activities and review of the SP visit reports· Bid Defence meetings and interactions with the sponsor. 
