Clinical Data Strategy Lead – Program & Operations

ABBVIE; Irvine (CA); On-site; USD 110,000 - 209,000; Full time

Benefits offered by this job

Paid time off

401(k)

Job summary

AbbVie is seeking a CDSO Lead or Clinical Data Scientist to act as the data management domain expert and strategic partner for clinical studies. You will own data collection strategies, drive implementations, ensure data quality, and support on-time milestones.

This role requires strong PM and cross-functional collaboration across regulatory, safety, and tech teams. The candidate will lead study data flow, SDTM mapping, and data mining to enable inspection readiness and robust study decisions,

Qualifications

• Bachelor's degree in business, MIS, CS, life sciences or equivalent. Master’s preferred.
• 6+ years of pharma/clinical research/data management/healthcare experience or 8+ years of PM experience.

Responsibilities

• Serve as 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 from study start-up through database lock with centralized monitoring and analytics.
• Triages data quality standards across studies, drives site actions, and maintains data currency for timely study decisions.
• Interpret clinical and operational data, quality metrics, predictive signals, and dashboards to develop data-driven recommendations.
• Define and manage study data flow and triage issues from raw EDC to mapped SDTM data with internal teams and vendors.
• Perform data mining and custom analytics, gather requirements for study dashboards, and generate operational metrics.

Skills

Leadership

Influence without authority

Communication

Analytical skills

Education

Bachelor's degree in business/MS/CS/life sciences

Master's degree preferred

Job description

AbbVie is seeking a CDSO Lead or Clinical Data Scientist to act as the data management domain expert and strategic partner for clinical studies. You will own data collection strategies, drive implementations, ensure data quality, and support on-time milestones.

This role requires strong PM and cross-functional collaboration across regulatory, safety, and tech teams. The candidate will lead study data flow, SDTM mapping, and data mining to enable inspection readiness and robust study decisions,