Medical Monitor

ROLE AND RESPONSIBILITIES• 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: • Detection of trends and outliers • Signal detection • Eligibility check • Review of selected laboratory parameters • Protocol deviations review with proposed grading from medical/safety perspective • Review of subject discontinuation list • Monitoring of specific safety parameters (risks due to IMP or AxMP safety profile as well as 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) and • Presentation 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 QUALIFICATIONS• Medical Doctor degree.