Data Strategy Lead - Hybrid

Purpose:
The Clinical Data Strategy and Operations (CDSO) Data Strategy Lead serves as the study start-up domain expert and key strategic partner to the clinical study team, owning all data-related study start-up deliverables from protocol development through system design and go-live. Leads cross-functional collaboration to embed data strategies, standards, and technologies into clinical plans, translating complex concepts into actionable decisions.

Responsibilities:
- Serve as the CDSO study start-up subject matter expert and single point of contact for assigned studies; own all data-related start-up deliverables from protocol development through system go-live.
- Lead data management study start-up end-to-end; optimize execution, track progress, and escalate/resolve issues affecting timelines or quality.
- Ensure consistency in data strategy, standards, CRFs, and surveillance approaches across studies and therapeutic area(s); provide clear guidance.
- Drive pull-through of critical-to-quality factors and data criticality assessments into downstream data systems.
- Ensure adherence to federal/local regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards.
- Influence without direct authority using data/evidence to drive aligned outcomes.
- Lead CDSO innovation and process improvement initiatives; participate in cross-functional initiatives.
- Coach and mentor team members.

Qualifications:
- Bachelor’s in business/management information systems/computer science/life sciences (or equivalent); Master’s preferred. PMP or Lean Six Sigma Green Belt desired.
- 6+ years pharma/clinical research/data management/healthcare experience OR 8+ years project management experience.
- In-depth understanding of clinical trial processes and clinical technology; lead clinical trial management preferred.
- Demonstrated functional leadership, ability to influence, coaching/mentoring in matrix environments, communication, and analytical skills.

This role is hybrid: 3 days/week onsite.