Sr. Medical Monitor (extensive oncology experience required)

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