Central Monitor

Central Monitoring and Risk Management is at the heart of AbbVies endtoend RBQM model a critical pillar required in AbbVies mission to be a worldclass R&D organization.
The purpose of the Central Monitor is to derisk studies as early as possible by analyzing data at the macrolevel for insights that are not visible when monitoring individual data points /study sites thereby enabling AbbVie to take early interventions to mitigate potential risks to the patient the investigator the data the study and the AbbVie business.

The Central Monitor works closely with their AllForOne AbbVie crossfunctional colleagues (i.e. primary site monitor safety data sciences and clinical study leadership) to ensure that they understand the data insight the significance of the implications and the root cause so that the crossfunctional team is able to Decide Smart And Sure on the appropriate actions/next steps to mitigate the risk and/or address the issue.
The Central Monitor is AbbVies first responder in identifying triaging and escalating study level risks.

The Central Monitor function is decentralized and includes team members from across the globe. Central Monitors are responsible for multiplejurisdiction studies with sites across the globe.

• Inspect nearrealtime 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) and Quality Tolerance Limits (QTLs) to identify significant issues and emerging risks at the study site program and country level.
• Clearly document detected issue / emerging risk.
• Translate the issue / emerging riskthe situation the significance / implication of the data insight and what further action is requiredbreaking down complex concepts into simple language.
• Communicate findings as per planned process to ensure that all crossfunctional stakeholders have the same understanding of the issue / emerging risk so that the appropriate followup action can be taken.
• Arm the primary site monitor with important information that will enable AbbVie to be the clinical partner of choice; allowing monitors to work differently 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 & Risk Management Meetings.
• Contribute to the ongoing development / advancement / improvement of the RBM systemsproviding 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 youre looking forward) and testing the system at the study level to ensure system quality.
• Be an RBQM champion across AbbVie supporting the of RBM processes as part of crossfunctional teams spanning the R&D portfolio (all therapeutic areas and phases of development).

Qualifications :

• Bachelors degree in related field may include life sciences riskbased discipline.
• Minimum of 3 years in clinical research monitoring.
• Experience working in an RBQMmodel or similar experience with riskbased environment preferred.
• Demonstrated current indepth 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 preferred in one of the following areas (Neuroscience Oncology Immunology Eye Care Medical Aesthetics Womens Healthcare GI).
• Embraces a curious mind set whilst evaluating data or conducting root cause analysis asking questions of the data in front of them not fulfilling preconceptions.
• Ability to anticipate and address critical issues and develop contingency plans proactively.
• Ability to learn and adapt quickly when facing new problems.
• Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
• Ability to work independently understand and follow work processes.

Additional Information :

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. 

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Work :

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