Director, Functional Area Geography Lead, External Data Management

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 areas 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 management.

• Broad expertise in risk-based data-management operations quality standards (GDMS GCTO Global Data Management & Standards Global Clinical Trial Operations) and the clinical trial lifecycle.

• Experience with data standards data flow and study start-up systems.

• Demonstrated ability to drive high-quality clinical data collection design validation and delivery in alignment with protocol requirements.

Non-technical knowledge skills and abilities

• Strong stakeholder management and collaboration capabilities fostering trust and effective partnerships to deliver consistent high-quality outcomes; influences senior leaders while giving clear actionable feedback to direct reports.

• Demonstrated ability to lead through influence motivating and guiding cross-functional and virtual teams without direct reporting authority; tailors messaging up across and down.

• Highly adaptable and resilient able to prioritize and perform effectively under pressure in a fast-changing environment.

• Works independently with accountability exercising sound judgment and initiative while maintaining alignment with organizational priorities.

• Effective facilitator of decision-making coordinating the work of others and driving timely resolution of complex issues that consider business operational and people dimensions.

• Creates career plans coaches continuously sponsors stretch assignments and prepares promotion cases to grow bench strength; fosters inclusion enables knowledge sharing and builds communities of practice.

• Recruits top talent; plans resources across regions and sourcing models (FTE Full Time Equivalent/contingent/on-/off-shore).

• Runs check-ins and reviews; recognizes excellence; addresses underperformance with documented improvement plans.

• Demonstrated ability to build and lead high-performing globally distributed teams.

• Fluent in English with excellent written and verbal communication skills to clearly convey complex or technical information.

Enterprise Leadership Skills

• Execution Excellence Drives reliable high-quality delivery within their team - developing core functional capabilities and KPI-driven measurement approaches (e.g. time-to-lock query rates error reduction) to track progress improve outcomes and support consistent submission-ready outputs across studies.

• Strategic Planning Thinks strategically within the assigned scope and gains alignment through collaborative stakeholder engagement and influence across development clinical operations regulatory safety and IT.

• Networking & Partnerships Builds and sustains strategic internal and external relationships (cross-functional leaders service providers alliance partners customers) within the assigned scope to advance functional area objectives.

Qualifications & Experience

• Bachelors Degree (or equivalent educational experience) in Life science Data or Information technology with 10 years of experience in data management including:

• 3 years of people management experience

• Demonstrated experience in clinical data management clinical trial operations and managing large diverse global teams

OR

• Bachelors Degree (or equivalent educational experience) in any field not listed above with 15 years of experience in data management including:

• 3 years of people management experience

• Demonstrated experience in clinical data management clinical trial operations and managing large diverse global teams

OR

• Advanced Degree (Masters or Doctorate) in Life Science Data Information Technology Project Management or Business with 8 years of related industry experience in data management including:

• 3 years of people management experience

• Demonstrated experience in clinical data management clinical trial operations and managing large diverse global teams

OR

• Advanced Degree (Masters or Doctorate) in any field not listed above with 13 years of related industry experience in data management including:

• 3 years of people management experience

• Demonstrated experience in clinical data management clinical trial operations and managing large diverse global teams

Required Skills:

Preferred Skills:

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