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

Senior Director, Functional Area Geography Lead, GDMS Clinical Data Management (CDM Country Lead) 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 (dashboards, capacity models) to inform resourcing, planning, and operational decisions. Ability to define and enforce standards for integration, reuse, and scalability of data, tools, and solutions. Proven financial stewardship, including budget ownership, workforce cost modeling, and development of investment/value realization frameworks. Knowledge of local-subsidiary operations (HR, vendors, facilities, finance) and local compliance expectations. Expertise in data-product governance (definitions, lineage, quality controls, lifecycle) to maintain a global single source of truth. Clinical Data Manager – Specific Technical Skills 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. Non-technical Skills Strategic leadership with the ability to align diverse, cross-functional, and virtual teams and stakeholders around shared objectives. Strong ability in negotiation and conflict resolution; aligning divergent priorities to enterprise outcomes and enforces clear responsibilities. Effective facilitation of decision-making, coordinating work across teams and driving timely resolution of complex issues. Change leadership, including executive influence and storytelling to shape decisions across senior leadership levels; ability to communicate with both the technical and business areas. Demonstrated ability to drive large-scale change, embed innovation, and lead continuous improvement initiatives, while ensuring adoption of standardized, risk-based, and digital practices. Strong people leadership, mentoring, and development capabilities across multiple levels and geography; create a high-performance, inclusive culture that attracts, develops, and retains talent. Ability to integrate business, operational, and people dimensions into effective decision-making; demonstrated budget and business acumen. Highly adaptable and resilient, able to prioritize and perform effectively under pressure. Demonstrated disciplined prioritization focused on critical metrics and initiatives. Works independently with sound judgment, exercising initiative while maintaining alignment with organizational priorities. Tailors messaging up, across, and down with clear, actionable feedback to direct reports. Capability building focused on senior-level talent development and communities of practice. Fluent in English with excellent written and verbal communication skills to clearly convey complex or technical information. Enterprise Leadership Skills Talent Growth | Build and sustain organizational talent for the geography by establishing systems to attract, develop, engage, and retain top performers, and by fostering an environment where people can realize their full potential to meet current and future business needs. Strategic Planning | Thinks strategically and gains alignment through collaborative stakeholder engagement and influence across development, clinical operations, regulatory, safety, and IT. Networking & Partnerships | Proactively builds and sustains strategic internal and external relationships (cross functional leaders, service providers, alliance partners, customers) to accelerate functional area and geography-specific objectives. Bachelor's Degree (13 years) – Data Management Bachelor's Degree (or equivalent educational experience) in Life science, Data or Information technology with 13 years of experience in data management, including: 5 years of people management experience Demonstrated experience in clinical data management, clinical trial operations, and managing large diverse global teams. Bachelor's Degree (18 years) – Any Field Bachelor's Degree (or equivalent educational experience) in any field not listed above with 18 years of experience in data management, including: 5 years of people management experience Demonstrated experience in clinical data management, clinical trial operations, and managing large diverse global teams Advanced Degree (Masters or Doctorate) – Life Science Advanced Degree (Masters Or Doctorate) In Life Science, Data, Information Technology, Project Management Or Business With 10 Years Of Related Industry Experience In Data Management, Including: 5 years of people management experience Demonstrated experience in clinical data management, clinical trial operations, and managing large diverse global teams Advanced Degree (Masters or Doctorate) – Any Field Advanced Degree (Masters Or Doctorate) In Any Field Not Listed Above With 15 Years Of Related Industry Experience In Data Management, Including: 5 years of people management Demonstrated experience in clinical management, clinical trial operations and managing large diverse global teams Required Skills Business Decisions, Business Decisions, Change Management, Clinical Data Management, Clinical Study Management, Clinical Study Protocols, Collaborative Leadership, Competency Development, Conflict Management, Data Analysis, Data Governance, Data Management, Data Processing, Data Validation, Decision Making, Ethical Standards, Executive Leadership, Good Clinical Practice (GCP), Influencing Skills, Leadership Theories, Operating Models, People Leadership, Situational Leadership, Strategic Alignment, Strategic Leadership {+ 2 more} US And Puerto Rico Residents Only Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. San Francisco Residents Only We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Employee Status: Regular Relocation: International VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 08/24/2026 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. #J-18808-Ljbffr Merck