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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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 Sr. 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 Senior Central Monitor does this by bringing their deep clinical monitoring expertise together
with the power of data analytics. The Senior Central Monitor analyzes near-real time aggregate
study and operational data for early Key Risk Indicators of potential study risks (i.e. data trends—
non-compliance 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 Senior 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 Senior Central Monitor is AbbVie’s first responder in identifying, triaging, and escalating
study-level risks.
The Senior 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.

• The Senior Central Monitor is the higher level of two roles in the Central Monitor job family and is responsible for more complex assignments (e.g., enterprise critical trials), an increased trial workload, support and lead initiatives and/or responsibilities as a peer mentor.

Responsibilities:

• Review protocol and ensure 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 role of central monitor.
• 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.
• Use Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) to identify significant issues and emerging risks at the study site, program, country.
• Clearly document the 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 including senior leaders 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, cross-functional departments and senior leaders.
• Participate in Health of Study and Risk Management Meetings.
• Coach and mentor junior and peer Central Monitor, as well as advise their managers on actual challenges they’re facing.
• Assigned to challenging spaces such as Enterprise Critical programs (where the criticality of delivery requires proactive planning for execution on deliverables, seamless responsiveness to work volume increases, complex therapeutic areas (where enhanced skill building and, unique study types etc.
• 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 5 years of clinically related or data trend analysis experience; at least 4 years of clinical research monitoring.
• Experience working in an RBQM-model or similar experience with risk-based environment required.
• 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

• Embraces the role of “first responder” in the pursuit of quality through data analytics.
• Advanced 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 curios mind set whilst evaluating data or conducting root cause analysis, asking questions of the data in front of them, not fulfilling preconceptions.
• Advanced ability to use critical thinking, functional expertise, and good judgement in support of objective, pragmatic SMART SURE decision making to drive effective and timely outcomes.
• Advanced ability to anticipate and address critical issues and develop contingency plans proactively.
• Ability to learn and adapt quickly when facing new problems.

Interpersonal & Communication Skills

• Acts with integrity in accordance with ABBVIE code of business conduct.
• Ambassador for RBQM within the organization, promoting value of early detection in derisking studies.
• Strong English language skills—spoken, written, and conversational.
• Collaborative team player who assumes positive intent and builds strong working relationships within the team and cross-functionally respecting and valuing diversity of expertise, experience, and perspective.
• Excellent interpersonal skills with the ability to communicate to inform, influence, convince and persuade with clarity.
• Advanced ability to break down complex technical, data and clinical concepts into simple language to convey importance / significance to ONE-FOR-ALL-ABBVIE stakeholders in written documentation and verbally in Health of the Study meetings.
• Able to articulate requirements for advanced/new dashboards and tools to the clinical analytics development department.
• Open and receptive to the gift of feedback in the pursuit of continuous improvement.

Organizational Skills

• Leads initiatives within and across teams.
• 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.

Computer Skills

• Passionate about leveraging power of technology and data analytics to drive better high quality results for AbbVie, investigators, and patients.
• Advanced proficiency with use/operation of data analytics and visualization tools daily in support of core responsibilities.
• Competent with Microsoft Office applications (Outlook, Word, Excel, PowerPoint, and Teams)

Key Stakeholders
Peers & Colleagues: Clinical Site Management (CSM); Clinical Study Leadership (CSL); Strategic
Clinical Operations; Therapeutic Area Medical Directors (TA MDs); Data Science Strategy &
Operations; Data Analytics; Clinical Trial Patient Safety; Compliance.

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.

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