Clinical Data Strategy Lead

Allergan; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie is seeking a CDSO Lead or Clinical Data Scientist to own data collection strategy, drive implementation, ensure data quality, and support on-time study milestones. As the data operations single point of contact, you will apply project management, risk oversight, and process optimization to enable data integrity, inspection readiness, and successful trial delivery.

Mentor and coach team members while collaborating with clinical, statistical, medical, safety, regulatory, technology, and

Qualifications

• Bachelor’s degree in business, MIS, CS, life sciences or equivalent; Masters preferred.

Responsibilities

• Serve as the CDSO data management SME and single point of contact for assigned studies, owning data collection, data cleaning, and database lock strategies.
• Lead 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.

Skills

Functional leadership

Influence without authority

Coaching/Mentoring

Communication skills

Analytical skills

Data management experience

Education

Bachelor’s degree or Master’s preferred

Job description

AbbVie is seeking a CDSO Lead or Clinical Data Scientist to own data collection strategy, drive implementation, ensure data quality, and support on-time study milestones. As the data operations single point of contact, you will apply project management, risk oversight, and process optimization to enable data integrity, inspection readiness, and successful trial delivery.

Mentor and coach team members while collaborating with clinical, statistical, medical, safety, regulatory, technology, and