Clinical Research 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 responsible for the execution of key Central monitoring activities. This includes site, subject, and study level review as applicable. The Central Monitoring Associate Manager collaborates within a matrix environment, communicates proactively internally and externally, and across functions with key stakeholders to ensure Central Monitoring is proactively and effectively executed to meet client expectations.

Main Responsibilities
  • Perform Central monitoring activities for multiple studies for customers and ensure accurate tracking and status reporting of studies.
  • Act as the Lead for the Central Monitoring team for more than one study for multiple customers.
  • Support Manager and leadership in preparation of detailed study risk assessment and in Sponsor presentations/bid defenses.
  • Ensure that tracking and status reporting are performed in a timely and accurate manner.
  • Contribute to the Risk Assessment and Categorization Tool (RACT) for topics related to Central Monitoring and/or medical reviews and consider risks when planning tools configuration.
  • Support the Data Expert with Critical Data and Process Definition and EDC design implementation.
  • Support the development of informatics Platform requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
  • Collate 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.
  • Edit the Central Monitoring and other applicable plans in line with emerging risk profile and study changes.
  • Populate the tools, test variable risk factors, adjust trigger levels, study-specific risk factors, and Central Monitoring parameters.
  • Perform ongoing reviews, prepare and recommend mitigation actions, and review recommended monitoring levels with project team and ensure that identified issues are followed to resolution.
  • Propose potential changes to monitoring intervention level on behalf of the project team in line with overall strategies.
  • Prepare and distribute the 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 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, e.g., project management, clinical monitoring, data management, and informatics.
  • Fluent English.
  • End-to-End RBQM experience is preferred.

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