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 and translate complex data/technology concepts into actionable decisions.
Responsibilities:
- Act as 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; partner within CDSO and across the study team to enable on-time study start; use analytics/project tools to optimize execution, track progress, and escalate/resolve issues impacting timelines or quality.
- Ensure consistency in data strategy, standards, CRFs, and surveillance approaches across studies/therapeutic areas; provide decision-ready guidance.
- Drive pull-through of critical-to-quality factors and data criticality assessments into downstream data systems.
- Ensure adherence to applicable regulations, Good Clinical Practices (GCP), ICH Guidelines, AbbVie SOPs, and quality standards; stay abreast of evolving guidance.
- Influence without direct authority using data/evidence; lead innovation and process improvement initiatives.
- Coach and mentor team members.
This role is hybrid (3 days/week onsite).
Qualifications:
- Bachelorโs degree (business, MIS, computer science, life sciences or equivalent); Masterโs preferred. PMP or Lean Six Sigma Green Belt desired.
- 6+ years in pharma/clinical research/data management/healthcare or 8+ years in project management (or applicable experience).
- In-depth understanding of clinical trial processes and clinical technology (lead role through initiation-to-completion preferred).
- Demonstrated functional leadership; ability to influence in matrix; coach/mentor; effective communication and analytical skills.