Executive Director, Clinical Data Management TA Head, EDEV & OED Lead

Job Description

Reporting directly to the Head of Clinical Data Management and serving as a member of the Clinical Data Manager Leadership Team, the Executive Director, Clinical Data Manager TA Head provides global leadership and strategic direction for one or more therapeutic areas. The role defines and executes the TA strategy, operating model, and innovation roadmap to ensure scalability, quality, and enterprise alignment across GDMS. The Executive Director represents the TA organization in Clinical Data Manager, GDMS, and enterprise forums, shaping future strategy, driving transformation, and advancing capability development across all geographies.

Responsibilities

• Serve on the Clinical Data Manager (Clinical Data Management) Leadership Team and represent the Therapeutic Area across GDMS (Global Data Management & Standards), GCTO (Global Clinical Trial Operations), GCD (Global Clinical Development), and enterprise forums; set, communicate, and align TA (Therapeutic Area) objectives with GDMS strategy.

• Ensure Clinical Data Manager products and services meet Book-of-Business commitments for the Therapeutic Area, including Data Acquisition Tools (DAT - e.g., EDC, DHT-eCOA), edit checks, data validation tools, data integrity and review, external data integration, IVRS/IRT (Interactive Voice Response System/ Interactive Response Technology), and interim/final database locks.

• Partner with Clinical Data Manager Geographic Leadership to ensure seamless global delivery, effective knowledge sharing, in depth understanding of protocols, risk based data management and quality-by-design execution proportionate to study design and therapeutic area risk management across all in-scope data modalities.

• Partner with leaders across GDMS, GCTO, and GCD to drive consistent rollout and adoption of data management capabilities, including alignment of cross-regional ways of working with partners.

• Manage the Therapeutic Area Clinical Data Manager Budget under guidance of the Head of Clinical Data Manager; optimize spend, productivity, and resource allocation.

• Drive operational performance against cycle-time, quality, efficiency, and delivery commitments.

• Embed quality, inspection readiness, and regulatory compliance into TA-level operating models and execution.

• Direct the development, maintenance, and adoption of TA-specific standards and  business practices to ensure compliance with global regulatory requirements and internal quality standards.

• Partner, influence, and advise senior internal and external stakeholders (Clinical, Regulatory, Statistics, Country Operations, investigators, service providers); lead senior-level customer, service provider, and industry engagements.

• Sponsor or lead large-scale change and continuous improvement initiatives (including but not limited to process, standards, and platform / tools), driving harmonization of data management practices across the enterprise.

• Influence and lead the selection and evolution of data management systems, processes, and operating models to ensure future-ready, scalable capabilities.

• Provide strategic input to, and where accountable define, capability development objectives and roadmaps aligned to business needs, enterprise strategy, and industry best practices.

• Provide oversight of capability governance in alignment with GDMS and GCTO policies and enterprise digital and data initiatives.

• Set the people strategy for the TA; develop leaders; ensure global role clarity and decision rights; maintain a resilient, inclusive, high-performance culture.

• Set clear objectives aligned to organizational goals; assign work and set priorities.

• Conduct regular check-ins and annual reviews; coach for performance; provide recognition.

• Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.

• Lead recruiting and hiring; manage sensitive employee-relations matters in partnership with HR.

• Balance workloads to support value-added work and work–life sustainability; anticipate obstacles and adjust plans.

• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.

• Manage an operating budget and optimize spend against priorities.

• Align teams around a clear direction; facilitate team/functional meetings.

• Provide concise, decision-ready updates and status reporting to leadership and partners.

• Comprehensive knowledge of the clinical development lifecycle, data flow, and cross-functional dependencies (Clinical Operations, Biostatistics, Safety, Data Standards, Regulatory).

• Extensive knowledge in