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Senior Director Functional Area Geography Lead Clinical Data Management, External Data Management

Merck

North Wales (Upper Gwynedd), PA, US$173k – $273khybrid

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Job Description

The Senior Director, Functional Area Geography Lead, GDMS Clinical Data Management (CDM Country Lead) provides strategic direction and governance to ensure consistent data-management delivery, quality, and compliance. The role oversees resource optimization, operational performance, and organizational effectiveness, driving cross-functional alignment with functional and GDMS (Global Data Management & Standards) leadership to enhance delivery, talent development, and scalability within assigned country.

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

• Serve on the functional area's leadership team as assigned; represent geographic and functional perspectives in GDMS (Global Data Management & Standards) LT (Leadership Team)/enterprise forums and audits as needed.  

• Lead or participate in cross-functional collaborations with non-GDMS 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.

• Lead the operating model and optimization strategy for the assigned geography, integrating functional area and GDMS global strategic objectives.

• Actively identify and support functional area capability development and implementation aligned with industry best practices and business needs; drive adoption of technology across relevant organizations consistent with agreed-upon principles and organizational priorities.

• Inspire teams toward shared goals for the our Company's Clinical Development Portfolio, GCTO (Global Clinical Trial Operations) objectives, and cross-functional partners.

• As assigned, serve as the GDMS Site Head for the relevant country

• Partner with Country and Regional business support functions (e.g., HR, Finance) to enable local business priorities.

Operational Governance, Execution, & Cross-Functional Alignment: • Coordinate workforce planning, resource management, and operational performance.

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

• Ensure geography/functional inspection readiness and compliant operational controls, including for operational data, change management, and system releases.

• Evaluate and implement process/technology improvements that enhance scalability, standardization, and quality; support operating model adoption and change management.

• Lead complex cross-functional workstreams, focus areas to be determined based on needs of the organization from idea/design to implementation and value realization.

• Actively support and participate in metrics governance and performance reviews with Portfolio & Resource Operations Specialists to ensure transparent portfolio health and operational efficiency.

• Actively manage OKRs (Objectives and Key Results) and performance metrics for assigned geography in alignment with broader GDMS goals and priorities; monitor dashboards and drive accountability.

• Conduct enterprise and country scenario planning and implement resilience playbooks to ensure business continuity and protect critical work and service levels.

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

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 spend against priorities.

• Inspires and ensures that team leaders are effectively supporting and empowering their individual leaders.

Capability leadership (as assigned): • Sit on CDM leadership team as the representative for their assigned capability

• Accountable for defining the strategic objectives and roadmap for capability development initiatives aligned to business needs and industry best practices.

• Establish and oversee capability governance with GDMS / GCTO policies and enterprise digital / data initiatives.

• Own development of critical capabilities (tools, processes, skills) aligned to industry best practices.

• Drive consistent global rollout via playbooks, guidance, and implementation support; align cross-regional ways of working with partners.

Technical Skills • 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.

• Deep knowledge of ICH/GCP (International Council of Harmonization - Good Clinical Practices) guidelines and how they apply to clinical or safety data management activities.

• Understanding of regulatory requirements, quality frameworks, and inspection/audit processes; ability to support inspection/audit readiness.

• Proven experience implementing risk-based and digital data practices, using data and automation to improve focus and quality.

• Knowledge of geographic risk, escalation, and capacity management processes.

• Ability to use analytical and forecasting tools (das

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