Senior Clinical Data Strategy Lead

ABBVIE; North Chicago (IL); Presencial; USD 110.000 - 209.000; Jornada completa

Descripción de la vacante

AbbVie is seeking a CDSO Lead or Clinical Data Scientist to serve as the data management domain expert for the clinical study team. This role owns data collection strategy, drives implementation, ensures data quality, and supports on-time milestones as the primary point of contact for cross-functional stakeholders.

You will lead data review strategies, triage data quality, interpret clinical data and dashboards, and contribute to data-driven decisions across the development lifecycle.

Formación

• Bachelor’s degree in business, MIS, computer science, life sciences or equivalent. Master’s 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

Responsabilidades

• 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 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.

Conocimientos

Functional leadership

Influence without authority

Mentoring

Communication skills

Analytical skills

Project management

Educación

Bachelor’s degree in business, MIS, CS, life sciences or equivalent. Master’s preferred.

Descripción del empleo

AbbVie is seeking a CDSO Lead or Clinical Data Scientist to serve as the data management domain expert for the clinical study team. This role owns data collection strategy, drives implementation, ensures data quality, and supports on-time milestones as the primary point of contact for cross-functional stakeholders.

You will lead data review strategies, triage data quality, interpret clinical data and dashboards, and contribute to data-driven decisions across the development lifecycle.