Leads risk-based and continuous data review strategies from study start-up through database lock, leveraging centralized monitoring, statistical review, and clinical data science methodologies to proactively identify and mitigate study risks.
Triages data quality standards across studies to identify trends, drive site-level actions through effective cross-functional communication, and maintain data currency in support of timely, reliable study decisions.
Interprets clinical and operational data, quality metrics, predictive signals, and dashboard outputs to develop data-driven recommendations that strengthen study execution, risk management, patient safety oversight, and quality across the clinical development lifecycle.
Contributes to defining, managing, and monitoring data-driven protocol deviations.
Defines and manages study data flow and triages issues from raw EDC data through mapped SDTM data, partnering with internal technology teams, service providers, and vendors to drive timely mitigation and support end-to-end data integrity.
Performs data mining and custom analytics, gathers business requirements for study dashboards, and generates operational metrics that support study decisions.
Ensures adherence to federal and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and functional quality standards; stays abreast of evolving guidance.
Influences cross-functional stakeholders without direct authority, aligning clinical, statistical, medical, safety, regulatory, technology, and vendor organizations around data-driven decisions and clinical data science strategies.
Leads CDSO innovation and process improvement initiatives and participates in cross-functional efforts that improve operational effectiveness, scalability, and study delivery quality.
Coaches and mentors team members.
Qualifications
Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).
In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred.
Demonstrated performance as a functional leader
Demonstrated ability to influence others without direct authority
Demonstrated ability to successfully coach / mentor in a matrix environment
Demonstrated effective communication skills
Demonstrated effective analytical skills
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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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What AbbVie Has to Offer
Our work can—and does—have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.
