Director Functional Area Geography Lead, Clinical Data Management

About this role

Job Description

The Director, Functional Area Geography Lead provides strategic and operational oversight for all functional area activities within a defined geography and team. The role defines and executes regional plans, manages staff performance and succession, and ensures compliance with local and global requirements while fostering collaboration, innovation, and the adoption of standardized and digital data-management practices.

Responsibilities

Strategic Leadership & Geographic Strategy: • Provide strategic direction within assigned country or region; ensure consistent execution, quality, and compliance; develop region-specific objectives aligned with organizational priorities.

• Lead or participate in cross-functional collaborations with non-GDMS (Global Data Management & Standards) partners and enterprise support functions to achieve geographic strategic and operational objectives.

• Communicate clear narratives to executives on risks, trade-offs, and decisions; champion innovation, automation, and risk-based data-management practices; share lessons and maintain quality oversight across geographies.

• Define and lead the functional area's operating model and multi-year optimization strategy for the assigned geography, integrating functional area and GDMS global strategic objectives.

• Actively identify and support functional area-specific capability expansion aligned with industry best practices and business needs; drive adoption of technology-deployment principles across relevant GCTO (Global Clinical Trial Operations) organizations.

Operational Governance, Execution, & Cross-Functional Alignment: • Drive high-quality, compliant, decision-ready data products and processes that enable teams to meet critical regulatory, clinical, and operational milestones within assigned functional area.

• Ensure inspection readiness, adherence to regional processes, and compliant controls for operational data, processes, and system changes in partnership with global and functional quality/process leaders.

• Analyze trends and performance data to identify opportunities for efficiency, quality, and engagement improvements; communicate insights in governance or leadership forums.

• Lead or oversee regional risk, escalation, and capacity management processes.

• Collaborate with Portfolio & Resource Operations Specialists to forecast needs, optimize capacity, and implement data-driven performance dashboards; resolve resourcing/performance bottlenecks; ensure transparent portfolio health and operational efficiency.

• Provide concise, decision-ready updates and status reporting to leadership and cross-functional partners, ensuring effective flow of communication within geography.

• Serve as escalation point for country/regional issues and oversee regional risk, escalation, and capacity-management processes; ensure local regulatory, business, and labor compliance.

• Lead or participate in cross functional global projects to support continuous improvement, capability development, and alignment.

People Management & Talent Development: • Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.

• 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 and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.

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

• Manage an operating budget and optimize spending against priorities.

• Coaches, inspires and empowers team members, creating the support structures and clarity needed for high performance.

Technical skills: • Ability to use operational and quality metrics to monitor performance; applies operational metrics and service provider management frameworks to monitor quality, timelines, efficiency, and compliance with privacy/system validation requirements.

• Understanding of inspection-readiness or audit processes and the ability to apply compliant controls in collaboration with Process & Quality partners.

• Understanding of data privacy and system validation requirements.

• Advanced ability to use analytical and forecasting tools (e.g., dashboards, capacity models) to inform resourcing, planning, and operational decisions; ability to interpret and apply performance data and dashboards to drive decisions.

• Ability to define and enforce standards for integration, reuse, and scalability of data, tools, and solutions across regions.

• Experience implementing risk-based, digital, or automated data-management practices or tools.

• Proven financial stewardship of large organizations, including budget ownership, investment case development, workforce cost modeling, and value realization frameworks.

• Demonstrated ability to drive large-scale change, embed innovation, and lead continuous improvement initiatives, while ensuring adoption of standardized, risk-based, and digital practices.

• Proficiency with workload planning and resourcing systems; familiarity with continuous improvement methodologies.

• Understanding of local and global regulatory requirements, including 21 CFR Part 11.

  CDM Specific Technical skills • Strong understanding of end-to-end data management processes, including how data is collected, reviewed/cleaned, governed, and reported.

• Deep knowledge of International Council for Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and their application to clinical data management activities.

• Expertise in leading vendor strategy as assigned, including ecosystem design, SLA/SOW (Service Level Agreement/ Statement of Work) development, performance scorecard design, and contract risk manage

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