Senior Central Monitor

Job description

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Purpose: Central Monitoring and Risk Management is at the heart of AbbVie’s end-to-end RBQM model—a critical pillar required in AbbVie’s mission to be a world-class R&D organization. The purpose of the Sr. Central Monitor is to analyze & investigate study data utilizing Key Risk Indicators, Quality Tolerance Limits and Data Anomalies at the macro-level for insights that are not visible when monitoring individual data points and study sites. Observations, signals, and data presentations are provided to the primary site monitor or study team members as early as possible, to allow for interventions to mitigate potential risks to participant safety and data integrity. In addition, the Senior Central Monitor performs integrated data review of subject clinical trial data using a clinical data review platform. Study specific data checks, as outlined in the integrated data review plan data listings, are programmed to provide ease of review. The Senior Central Monitor works closely with cross-functional colleagues (i.e., primary site monitor, safety, data sciences, and clinical study leadership) to ensure that they understand the data insight and the root cause, to determine the appropriate actions to mitigate the risk and/or address the issue. The Senior Central Monitor is AbbVie’s first responder in identifying, triaging, and escalating studylevel risks. The Senior Central Monitor function includes team members from across the globe. The Senior Central Monitor will support more complex assignments, an increased trial workload, support and lead initiatives, and participate in peer mentoring. Central Monitors are responsible for multiple studies across many therapeutic areas. Responsibilities: Review the protocol and ensure the Integrated Data Review Plan is updated for the central monitor role within the study, ensuring key critical data is included in the plan aligned to the role of central monitor. Provide recommendations during initial Risk Management meetings on appropriate TA or study specific Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs). Inspect aggregate clinical and operational data from multiple sources (eCRF, vendor data, digital health/wearables, etc.). Utilize data analytics and visualizations to uncover insights and see complex patterns within data to perform review. Use Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Data Anomalies to identify significant issues and emerging risks at the study site, program, and country level. Document detected issues and emerging risks. Translate the issues and emerging risks by clearly outlining the situation, the significance or implications of data insight, and any further action required. Communicate findings as per planned process to ensure that all cross-functional stakeholders have the same understanding of the issues and emerging risks so that the appropriate follow-up action can be taken. Provide the primary site monitor with relevant information; allowing monitors to work with site staff and have more productive discussions with our Investigator partners. Work collaboratively in the pursuit of quality with the primary site monitor, the Study Team, and crossfunctional departments. Participate in Health of Study and Risk Management Meetings. Contribute to the ongoing development, advancement, and improvement of the RBQM systems—providing requirements that will further enable data analysis (i.e. what to look for, how to best present the data so that you can see what you’re looking forward) and testing the system at the study level to ensure system quality Assigned to challenging spaces where the criticality of delivery requires proactive planning for execution on deliverables, seamless responsiveness to work volume increases, and complex therapeutic areas. Be a RBQM champion across AbbVie, supporting the execution of RBQM processes as part of crossfunctional teams spanning the R&D portfolio (all therapeutic areas and phases of development). Qualifications: Education & Experience: Bachelor’s degree in related fields including life sciences and risk-based disciplines. Minimum of 5 years of clinically related or data trend analysis experience; at least 4 years of clinical research monitoring. Experience working in a RBQM model or similar experience with risk-based environment preferred. Demonstrated current in-depth knowledge and understanding or willingness to learn of appropriate therapeutic indications, regulations, and ICH/GCP guidelines as they relate to the conduct of clinical trials (study management, data management and regulatory operations). TA experience is preferred in one of the following areas (Neuroscience, Oncology, Immunology, Eye Care, and Aesthetics. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html