Executive Director, Clinical Data Management – Europe

Responsibilities

• Reporting directly to the Head of their assigned functional area and acting as a member of their Leadership Team
• Leads global geographic strategy and performance across assigned region / geography.
• Responsible for translating functional area and GDMS strategic imperatives into region-specific priorities and plans.
• Partners with GDMS and GCTO leaders to drive global alignment, standardization, and transformation of data-management practices
• Represents their function and geography network in GDMS LT forums, and ensure resource excellence, capability growth, and operational readiness worldwide.
• Oversee multiple regions/countries to ensure excellence in functional management and regulatory compliance.
• Collaborate with cross-functional (non-GDMS) leadership and enterprise support functions within assigned geographies to achieve strategic and operational goals and objectives.
• Embed process-excellence and governance frameworks across regions.
• Shape and implement digitally enabled operating models; drive global alignment, standardization, and transformation.
• Champion a culture of collaboration, innovation, and accountability across the network; ensure ongoing improvement and operational excellence.
• Partner with leaders across GDMS, GCTO, and Global Clinical Development (GCD) to drive consistent rollout / adoption of capabilities.
• Serve as escalation point for country/regional issues; oversee region-specific risk, escalation, and capacity-management processes; ensure local regulatory, business, and labor compliance.
• Drive adoption of leading-edge technology deployment principles across relevant GCTO organizations and functions.
• Lead complex cross-functional work streams driving automation, data integrity, and operational excellence from idea/design through implementation and value realization.
• Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.

• Minimum of bachelor's degree with 10+ years of leadership experience
• Enterprise-level expertise in GDMS data operations, governance, and digital enablement strategy.
• Strong understanding of end-to-end data management processes and systems used for data collection, application of data standards, cleaning/review, reporting, governance, and use of operational and quality metrics to monitor performance.
• Proven experience implementing risk-based and digital data practices across multiple regions; ability to integrate regional business intelligence into enterprise-level strategy.
• Deep understanding of inspection/audit processes and ability to contribute to audit readiness.
• Deep knowledge of ICH/GCP (International Council of Harmonization - Good Clinical Practices) guidelines and how they apply to clinical or safety data management activities.
• Deep understanding of quality standards and frameworks across GDMS/ GCTO; experience with data standards, data flow, and study start-up systems; ability to define and implement standards for integration, reuse, and scalability of data, tools, and solutions across regions.
• Advanced knowledge of data management industry best practices, innovation levers, and regulatory evolution shaping data management globally.
• Deep expertise in data-product governance (definitions, lineage, quality controls, lifecycle) to maintain a global single source of truth; deep understanding of clinical trial lifecycle.
• Advanced knowledge of regional risk, escalation, and capacity-management processes.
• Advanced ability to use analytical and forecasting tools (dashboards, capacity models) to inform resourcing, planning, and operational decisions.
• Ability to implement and execute inspection-readiness practices in collaboration with Process & Quality partners.
• Demonstrated ability to drive high-quality clinical data collection design, validation and delivery in alignment with protocol requirements.

• bachelor's degree
• GCP certification
• ICH certification