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. The role leads cross-functional collaboration to ensure data strategies, standards, and technologies are consistently embedded into clinical plans, while translating complex data and technology concepts into actionable decisions for the study team. Through strong project management, risk oversight, and continuous process optimization, the Data Strategy Lead is key to ensuring successful clinical trial technology delivery.​
Responsibilities:
​​Serves as the CDSO study start-up subject matter expert and single point of contact for assigned studies, owning all data-related start-up deliverables from protocol development through system go-live.
​Leads data management study start-up end-to-end, partnering both within CDSO and across the study team to enable on-time study start. Leverages operational analytics and project management tools to optimize execution, track progress, and escalate and resolve issues affecting timelines or quality.
​Ensures consistency in data strategy, standards, CRFs, and surveillance approaches across studies and therapeutic area(s). Translates complex data, technology, and standards concepts into clear, decision-ready guidance for study teams.
​Drives the pull-through of critical-to-quality factors and data criticality assessments, ensuring they are translated and implemented into downstream data systems.
​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 without direct authority, using data and evidence to drive aligned, mutually beneficial outcomes for AbbVie.
​Leads CDSO innovation and process improvement initiatives and participates in cross-functional initiatives.
​Responsible for coaching and mentoring team members.​
This role is a hybrid role with 3 days a week onsite.
Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired.
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

Employment type
Full-time

Work arrangement
Hybrid