Central Monitoring Associate Manager

hace 4 semanas


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

The Central Monitoring Associate Manager plays a crucial role in the execution of key Central monitoring activities, collaborating with stakeholders to ensure effective execution and meet client expectations.

Main Responsibilities
  • Perform Central monitoring activities for multiple studies, ensuring accurate tracking and status reporting.
  • Act as Lead for the Central Monitoring team for multiple studies and customers.
  • Support Manager and leadership in preparing 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 Central Monitoring and medical reviews.
  • Support the Data Expert with Critical Data and Process Definition and EDC design implementation.
  • Develop informatics Platform requirements, including design of visualizations and data feeds.
  • Collate requirements, including prescriptive risk factor mitigation strategies and SDV strategy.
  • Draft the Configuration Plan and other applicable Plans in collaboration with the study team.
  • Perform ongoing reviews, prepare and recommend mitigation actions, and review recommended monitoring levels.
  • Propose potential changes to monitoring intervention level on behalf of the project team.
  • Prepare and distribute Project/Study Reports at intervals during study conduct and at study close out.
Requirements
  • University/college degree or post-graduation (life science preferred) from an accredited institution.
  • Minimum of 6-8 years of relevant clinical research experience in a pharmaceutical company/CRO or equivalent experience with increasing levels of responsibility.
  • Fluent English.
  • End-to-End RBQM experience is preferred.


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