Central Monitoring Associate Manager

hace 5 días


Ciudad de México, Ciudad de México SAO Fortrea Brazil Limitada A tiempo completo
Job Summary

The Central Monitoring Associate Manager is a key role within our organization, responsible for the execution of critical Central monitoring activities. This position requires a strong understanding of clinical trials and a proven ability to collaborate with cross-functional teams to ensure seamless execution.

Key Responsibilities
  • Perform Central monitoring activities for multiple studies, ensuring accurate tracking and status reporting.
  • Act as the Lead for the Central Monitoring team for multiple studies, providing guidance and support to team members.
  • Support the development of detailed study risk assessments and sponsor presentations.
  • Ensure timely and accurate tracking and status reporting.
  • Contribute to the Risk Assessment and Categorization Tool (RACT) for topics related to Central Monitoring and medical reviews.
  • Support the Data Expert with Critical Data and Process Definition and EDC design implementation.
  • Support the development of informatics Platform requirements, including design of visualizations.
  • Collate requirements, including prescriptive risk factor mitigation strategies and SDV strategy.
  • Draft the Configuration Plan and all other applicable Plans in collaboration with the study team.
  • Populate the tools, test variable risk factors, and adjust trigger levels.
  • Perform ongoing reviews, prepare and recommend mitigation actions, and review recommended monitoring levels with the project team.
  • Propose potential changes to monitoring intervention level on behalf of the project team.
  • Prepare and distribute the Project/Study Reports at intervals during study conduct and at study close out.
Main Requirements
  • University/college degree or post-graduation (life science preferred) from an appropriately accredited institution.
  • Minimum of 6-8 years of relevant clinical research experience in a pharmaceutical company/CRO or other equivalent experience with increasing levels of responsibility in clinical trial-related roles.
  • Fluent English.
  • End-to-End RBQM experience is preferred.


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