Specialist II / Senior Specialist, Clinical Data Strategy and Operations Group, Japan Data and Statistical Sciences

The position is responsible for providing support to mainly Japan/China clinical development projects in the area of data management. The support is supplied in the context of a cooperative, one team mindset, project-oriented effort and included data capabilities in general planning and execution of clinical trials, data management activities of individual trials, and regulatory submissions and inspections.

• Serves as the subject matter expert and main point of contact for data management on assigned studies, primarily in Japan, China and other Asian countries/regions. Owns data-related start-up deliverables (e.g., eCRF, eCOA and IRT) from protocol development through system go-live, as well as strategies for data collection, data cleaning and database lock.
• Leads data management activities end-to-end, from study start-up through database lock, and is accountable for data management timelines. Works with the global data management function and the study team, and uses operational analytics and project management tools to track progress and to escalate and resolve issues affecting timelines or quality.
• Ensures that critical-to-quality (CtQ) factors and data criticality assessments are reflected in data collection design and downstream data systems.
• Performs risk-based, continuous data review using dashboards and quality metrics, triages data quality issues, and drives site-level actions through effective cross-functional communication to keep data current and reliable.
• Defines and manages study data flow from raw EDC data through mapped SDTM data, partnering with internal technology teams, service providers and vendors to support end-to-end data integrity.
• Ensures adherence to applicable regulations, GCP, ICH guidelines, AbbVie SOPs and functional quality standards, and stays up to date on evolving guidance.
• Supports regulatory submissions and maintains inspection readiness for assigned studies, including responses to health authority inspections (e.g., PMDA).
• Influences without direct authority in cross-functional study planning, translates complex data and technology concepts into clear guidance for study teams, and leads or contributes to process improvement initiatives. Senior Specialists are also expected to coach and mentor team members.