Director, Data Management Process, Quality & Inspection Readiness
Core
Strategic leadership for Data Management quality, inspection readiness, and process excellence within a global clinical development environment.
Role type
Director, Data Management Process, Quality & Inspection Readiness
Builds
Standardized, scalable, compliant, and inspection-ready Data Management processes and frameworks
Domain
Biotechnology / Pharmaceutical / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data management principles, GCP/ICH guidelines, 21 CFR Part 11, ALCOA+, CAPA processes, issue management, escalation frameworks, KQI/KPI frameworks, organizational change management, matrix organization leadership, cross-functional stakeholder influence
Preferred skills
Health authority inspection experience (FDA, PMDA, MHRA, EMA), SharePoint repository management, training framework development, SME network leadership
Technologies
SharePoint
Responsibilities
Provide strategic leadership for Data Management quality and compliance; Develop Data Management quality frameworks including CRO oversight and issue management; Lead Data Management inspection readiness and audit support; Establish and maintain Data Management process and training frameworks; Responsible for line management and performance of direct reports
Seniority
Director, strategic leadership & people management
