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.