Clinical Data Strategy Lead II — Data Operations

AbbVie

North Chicago (IL)

On-site

USD 120,000 - 180,000

Full time

14 days+
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Benefits offered by this job

Paid time off
Medical/dental/vision insurance
401(k)

Job summary

AbbVie in North Chicago is seeking a CDSO Lead or Clinical Data Scientist to own data collection strategies, oversee data quality, and support on-time study milestones.

As the data operations single point of contact for cross-functional stakeholders, you will apply project management, risk oversight, and continuous process optimization to enable data quality, inspection readiness, and successful trial delivery.

Qualifications

  • Bachelor’s degree in life sciences or related field; Masters preferred.
  • 6+ years pharma/clinical research or 8+ years project management experience.

Responsibilities

  • Serves as the CDSO data management subject matter expert and single point of contact for assigned studies, owning data collection, 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, drive site-level actions through 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.

Skills

Data management
Clinical data science
Project management
Cross-functional collaboration
Regulatory compliance

Education

Bachelor’s degree in life sciences / IT / related field
Masters preferred

Tools

EDC
SDTM

Job description

AbbVie in North Chicago is seeking a CDSO Lead or Clinical Data Scientist to own data collection strategies, oversee data quality, and support on-time study milestones.

As the data operations single point of contact for cross-functional stakeholders, you will apply project management, risk oversight, and continuous process optimization to enable data quality, inspection readiness, and successful trial delivery.

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