Senior Clinical Data Operations Lead

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The Clinical Data Strategy and Operations (CDSO)DMO Lead orClinical Data Scientist(CDS)serves as thedata managementdomain expert and key strategic partner to the clinical study team. This role owns thedata collection strategy,drivesimplementation, oversees data qualitydelivery,andsupportson-timeachievementofkeystudy milestones.AstheData Operationssingle point of contactforcross-functional stakeholders, the DMO Lead orCDSappliesstrong project management, risk oversight, and continuous process optimizationto enabledata quality, inspection readiness, andsuccessful trial delivery.

Responsibilities:

• Serves as the CDSO data management subject matter expert and single point of contact for assigned studies, owningdatacollection, data cleaning, and database lock strategies to enable high-quality, inspection-ready study delivery.
• 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,drivesite-level actions through effective cross-functional communication, and maintaindatacurrency in support of timely, reliable studydecisions.
• 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 fromrawEDC datathroughmapped 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 forstudydashboards, andgeneratesoperational metrics thatsupportstudy 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.Masterspreferred.
• 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 ispreferred.
• Demonstrated performance as afunctional 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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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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