Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

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 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 is AbbVie’s first responder in identifying, triaging, and escalating study level risks.

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.

• 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

• 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).
• 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, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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