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KEY ACCOUNTABILITIES:
The RBM Central monitor will
- Lead the kick-off meeting dedicated to RBM with the CTT
- Manage the activities for the set-up of RBM on a study
- Help the study team define appropriate Key risk Indicators
- Help the RBM data scientist define the analytical strategy (frequency of review, focus of analyses, by site, by country…) in conjunction with the Study Team (CTT)
- Review the data findings and signals with the RBM data scientist
- Coordinate review of RBM signals by the study team and provide recommendation on signal related action plan
- Review analysis to create site-specific signals to be used by Site Monitors (CRA)
- Support CRA in the use of RBM approach at site level
- Formalize an action plan for/jointly with the study team to be implemented as adapted RBM (frequency of visit, % sdv etc…)
- Closely collaborate with RBM Data Scientist and study team
- Follow RBM processes defined for the global and local team
- Provide mentoring to new RBM Central Monitor
- Support study team and monitoring teams for the use of CluePoints platform based on the RBM results of the study (in collaboration with RBM Data Scientist )
- Design and architect proper methods, technique and evaluation criteria for complex project
- Contribute to development of company concepts and principles in creative and effective ways
JOB-HOLDER ENTRY REQUIREMENTS:
Education:
A scientific or biomedical master degree and above or equivalent
Experience & knowledge:
- 5+ years’ experience in a Clinical Research environment (CRO or Pharma)
- Experience in Clinical Trial Management or Datamanagement
- Experience of site monitoring
- Able to interpret and explain atypical patterns in the clinical and operational data
- Has a good understanding of the theoretical and applied bases for one technology
- Has developed experience in solving complex problem and delivery with increased technical/business acumen
Core competencies:
- Good English oral and written communication skills
- High degree of accuracy and attention to detail is required