Director, Data Quality & Process, Clinical Data
Core
Functional lead for External Data Quality and Process across the clinical development portfolio, defining strategic roadmaps for operational excellence and governance.
Role type
Senior IC Director (Clinical Data Management)
Builds
Standardized processes, governance frameworks, metrics, and best practices for external data management.
Domain
Biotechnology / Clinical Research / External Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, portfolio-level thinking, project management, process improvement, cross-functional alignment, regulatory compliance (ICH-GCP, GCDMP), vendor oversight, inspection readiness, data quality management, SOP development, risk mitigation, training program design, mentorship.
Preferred skills
Oncology experience, advanced degree (MS/PhD), experience with AI/automation solutions.
Technologies
EDC systems, AI solutions, Cloud platforms, GCP Support tools.
Responsibilities
Define and execute strategic roadmap for external data quality and operational excellence; lead cross-functional initiatives for organizational growth and scalability; advise senior leadership on external data strategy and operational risks; develop and govern external data management processes, standards, and SOPs; provide strategic oversight of CROs and external data vendors; lead inspection-readiness strategy and support audits; mentor team members and develop future leaders; represent the company in industry initiatives and external working groups.
Seniority
Director, strategic leadership & mentorship
