Medical guidance to site personnel and the project team regarding Protocol and other studyspecific medical aspects
24/7 medical consultancy support to investigators and project team
Monitoring of patients safety and wellbeing:
o Detection of trends and outliers
o Signal detection
o Eligibility check
o Review of selected laboratory parameters
o Protocol deviations review with proposed grading from medical/safety perspective
o Review of subject discontinuation list
o 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 studyrelated documents (including the preparation of the MM plan)
Participation in Kickoff Meetings Investigator Meetings and other studyrelated 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 recoding of events if appropriate Overview of SP activities and review of the SP visit reports
Bid Defence meetings and interactions with the sponsor.
Qualifications :
Remote Work :
Yes
Employment Type :
Fulltime
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