Central Monitoring Associate Manager
About this role
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Skills you'll use
What you'll do
- Performs the Central monitoring activities for multiple studies for customers and ensures accurate tracking and status reporting of studies in their remit.
- Act as the Lead for the Central Monitoring team for more than one studies for multiple customers.
- Support Manager and leadership in preparation of detailed study risk assessment and in Sponsor presentations / bid defenses.
- Ensures that tracking and status reporting are performed in a timely and accurate manner.
- Contributes to the Risk Assessment and Categorization Tool (RACT) for topics related to central Monitoring and/or medical reviews and considers risks when planning tools configuration.
- Supports the Data Expert with Critical Data and Process Definition and EDC design implementation.
- Supports the development of informatics Platform requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
- Collates requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable risk factor trigger levels.
- Draft the Configuration Plan and all other applicable Plans in collaboration with the study team and update these on an ongoing basis including the refinement of visualizations and any edits in line with emerging risk profile and study changes.
- Edits the Central Monitoring and other applicable plans in line with emerging risk profile and study changes.
Who can apply
- University / college degree from an appropriately accredited institution.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
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