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 workstreams 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.
Requirements
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.
Certifications & Qualifications
bachelor's degree
GCP certification
ICH certification
#J-18808-Ljbffr
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 workstreams 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.
Requirements
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.
Certifications & Qualifications
bachelor's degree
GCP certification
ICH certification
#J-18808-Ljbffr
Executive Director, Clinical Data Management – Europe Arbeitgeber: Jobtailor
Als Global Director B2B – Business Development bei uns profitieren Sie von einer dynamischen und innovativen Arbeitsumgebung, die auf Zusammenarbeit und Kreativität setzt. Wir bieten Ihnen nicht nur attraktive Vergütungsmodelle und umfassende Weiterbildungsmöglichkeiten, sondern auch die Chance, in einem internationalen Team zu arbeiten, das Vielfalt und persönliche Entwicklung fördert. Unsere Unternehmenskultur legt großen Wert auf Flexibilität und Work-Life-Balance, sodass Sie Ihre Karriereziele in einem unterstützenden Umfeld erreichen können.
