Central Monitor I

hace 2 meses

Ciudad de México CDMX AbbVie A tiempo completo

**Company Description**

Position based in Mexico, 100% remote.

**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 Central Monitor is to de-risk studies as early as possible by analyzing data at the macro-level 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 does this by bringing their deep clinical monitoring expertise together with the power of data analytics. The Central Monitor analyzes near-real time aggregate study and operational data for early Key Risk Indicators of potential study risks (i.e. data trends—noncompliance with study protocols, study patient selection, anomalies/outliers, and so on; as well as within different site segments—sites new to clinical research, sites in new countries and underperforming sites etc.) and initiates the appropriate action to fully investigate the data insight so that the appropriate next steps can be taken to mitigate the potential risk.

The Central Monitor works closely with their All-For-One AbbVie cross-functional 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 cross-functional 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 function is de-centralized and includes team members from across the globe. Central Monitors are responsible for multiple-jurisdiction studies with sites across the globe.

**Responsibilities**:

- Inspect near-real-time 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 risk—the situation, the significance / implication of the data insight, and what further action is required—breaking down complex concepts into simple language.
- Communicate findings as per planned process to ensure that all cross-functional stakeholders have the same understanding of the issue / emerging risk so that the appropriate follow-up 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 cross-functional departments.
- Participate in Health of Study & Risk Management Meetings.
- Contribute to the ongoing development / advancement / improvement of the RBM 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.
- Be an RBQM champion across AbbVie, supporting the execution of RBM processes as part of cross-functional teams spanning the R&D portfolio (all therapeutic areas and phases of development).

**Qualifications** Education & Experience**
- Bachelors degree in related field, may include life sciences, risk-based discipline.
- Minimum of 3 years in clinical research monitoring.
- Experience working in an 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 preferred in one of the following areas (Neuroscience, Oncology, Immunology, Eye Care, Medical Aesthetics, Women’s Healthcare, GI).

**Analytic & Critical Thinking Skills**
- Ability to evaluate large volumes of data from multiple sources and complex issues from multiple perspectives, to identify and investigate atypical patterns/trends, to conduct root cause analysis, and to effectively raise issues to ALL-FOR-ONE-ABBVIE stakeholders for appropriate corrective action.
- 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 use critical

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