Central Monitoring Manager

hace 1 día

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

As a leading global contract research organization (CRO), SAO Fortrea Brazil Limitada provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

Job Summary

The Central Monitoring Manager plays a critical role in ensuring the full implementation of the risk plan and recommending appropriate changes to ongoing monitoring. This position collaborates within a matrix environment, communicates proactively internally and externally, and across functions with key stakeholders to ensure plans are proactively and effectively executed to meet client expectations.

Main Responsibilities

  • Perform central monitoring activities for multiple studies and ensure accurate tracking and status reporting of studies within their remit.
  • Manage a portfolio of studies for a customer and act as a customer point of contact.
  • Collaborate in the development of central monitoring proposals, review of costing, and contribute to proposal strategy and development.
  • Collaborate in the development of sponsor presentations and bid defense support.
  • Oversee at a study/customer level the appropriate tracking, interpretation, and application of data to proactively manage risk.
  • Ensure that tracking and status reporting are performed in a timely and accurate manner.
  • Apply data to recommend any required changes.
  • Lead, plan, prepare, conduct, and follow up central monitoring activities and support less experienced team members.
  • Support the Project Management Office (PMO) in the preparation of the initial Risk Management Register and may prepare, distribute, and follow up Study Risk Impact Reports and coordinate Site Risk Weighting.
  • Ensure Critical Data & Process Definition are implemented in EDC design by Data Expert.
  • Conduct Site Risk Assessment across multiple studies, work with study start-up team members, review site outreach, Pre-Study Visit reports, and Site Risk Assessment. Prepare site risk stratifications and propose baseline site risk levels and initial site monitoring intervention levels.
  • Develop and establish requirements, including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels.
  • Develop the Central Monitoring and other applicable plans and any subsequent changes.
  • Manage the configuration of tools, risk factors trigger levels, programming of study-specific risk factors, and central monitoring parameters and perform user acceptance testing of applicable tools.
  • Perform ongoing dashboard reviews, prepare and recommend mitigation actions, and review recommended monitoring levels with project teams and ensure that identified issues are followed to resolution.
  • Agree potential changes to monitoring intervention levels with project teams in line with applicable plans and escalate appropriately.
  • Perform subject clinical reviews and take appropriate actions as applicable.
  • Perform study analytics reviews as per applicable plans and communicate findings appropriately.
  • Review and Approve changes to monitoring levels, ensuring compliance with applicable plans and sponsor needs.
  • Oversee Project Quality and Risk Reports to ensure client satisfaction and compliance.
  • Coach assigned project teams internally and externally to increase central monitoring competence.
  • Contribute to the development and maintenance of processes, including SOP writing, process mapping, and process improvements using Six Sigma and LEAN methodologies.
  • Evaluate and collate process improvement suggestions and submit to leadership.
  • Evaluate and submit ideas and justification for improved systems and tools to leadership.

Requirements

  • University/college degree or post-graduation (life science preferred) from an appropriately accredited institution.
  • Minimum of 7-9 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.

SAO Fortrea Brazil Limitada is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We offer a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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