Executive Director, Clinical Data Management, USA Lead

Job Description Reporting directly to the Head of their assigned functional area and acting as a member of their Leadership Team, the Executive Director, Regional Lead - USA, leads global geographic strategy and performance across assigned region/ geography. They are responsible for translating functional area and Global Data Management and Standards ( GDMS) strategic imperatives into region-specific priorities and plans. The role partners with GDMS and Global Clinical Trial Operations ( GCTO) leaders to drive global alignment, standardization, and transformation of data-management practices, represent their function and geography network in GDMS LT forums, and ensure resource excellence, capability growth, and operational readiness worldwide. Primary Responsibilities: Strategic Leadership & Geographic Strategy: Lead global geography strategy and oversee multiple regions/countries to ensure excellence in functional management and regulatory compliance, while embodying ELS (Enterprise Leadership Skills) values. Report to the functional area head; serve on the respective functional area leadership team; represent geographic and functional perspectives in GDMS (Global Data Management & Standards) Leadership Team, enterprise forums, and audits for assigned regions. Collaborate with cross-functional (non-GDMS) leadership and enterprise support functions within assigned geographies to achieve strategic and operational goals and objectives. Embed process-excellence and governance frameworks across regions. Shape and implement digitally enabled operating models; drive global alignment, standardization, and transformation. Champion a culture of collaboration, innovation, and accountability across the network; ensure ongoing improvement and operational excellence. Partner with leaders across GDMS, GCTO, and Global Clinical Development (GCD) to drive consistent rollout / adoption of capabilities, including alignment of cross-regional ways of working with partners. Oversee performance governance, financial discipline, and global talent planning; sponsor leadership development and succession As assigned, serve as the GDMS Site Head for the relevant country or region Partner with Country and Regional business support functions (e.g., HR, Finance) to enable local business priorities. Operational Governance, Execution, & Cross-Functional Alignment: Ensure consistent operational execution, quality, and compliance across assigned geographies. Jointly accountable with Portfolio & Resource Operations and non-GDMS leaders for planning, resourcing, and operational governance across regions; set priorities for resource allocation, capability development, and continuous improvement or process innovation to achieve strategic and operational goals. Serve as escalation point for country/regional issues; and oversee region-specific risk, escalation, and capacity-management processes; ensure local regulatory, business, and labor compliance. Drive adoption of leading-edge technology deployment principles across relevant GCTO organizations and functions. Lead complex cross-functional workstreams driving automation, data integrity, and operational excellence from idea/design through implementation and value realization. Run geography scenario planning and resilience playbooks for demand shocks, surges, and reprioritization; protect critical work and service levels. Champion a culture of collaboration, innovation, and accountability across the GDMS network. Capability leadership (as assigned): Regional Leader - USA will oversee the Global Capability Leaders (approximately 4) for Clinical Data Management Organization.- Description of Capability Leadership responsibilities are below: 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. Provide strategic input and feedback to Capability Leads on capability development initiatives, including capability roadmaps and strategic objectives. 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. Required Experience and Skills: Technical Skills: Enterprise-level expertise in GDMS data operations, governance, and digital enablement strategy. 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. Proven experience implementing risk-based and digital data practices across multiple regions; ability to integrate regional business intelligence into enterprise-level strategy. Deep understanding of inspection/audit processes and ability to contribute to audit readiness. Deep knowledge of ICH/GCP (International Council of Harmonization - Good Clinical Practices) guidelines and how they apply to clinical or safety data management activities. Deep understanding of quality standards and frameworks across GDMS/ GCTO; experience with data standards, data flow, and study start-up systems; ability to define and implement standards for integration, reuse, and scalability of data, tools, and solutions across regions. Advanced knowledge of data management industry best practices, innovation levers, and regulatory evolution shaping data management globally. Deep expertise in data-product governance (definitions, lineage, quality controls, lifecycle) to maintain a global single source of truth; deep understanding of clinical trial lifecycle. Advanced knowledge of regional risk, escalation, and capacity-management processes. Advanced ability to use analytical and forecasting tools (dashboards, capacity models) to inform resourcing, planning, and operational decisions. Clinical Data Management-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 knowledge, skills, and abilities: Executive communication and storytelling skills with the ability to influence senior leadership decisions. Strong stakeholder management demonstrated enterprise leadership, and collaboration capabilities across functions and geographies. Demonstrated ability to lead through influence, motivating and guiding cross-functional and virtual teams without direct authority. Ability to integrate business, operational, and people dimensions into effective, data-informed decision-making. Ability to shape culture, guide transformation, and build organizational capability at scale. Strong governance judgment balancing compliance, quality, delivery, and innovation. Tailors messaging up, across, and down; engages stakeholders; influences senior leaders and provides clear, actionable feedback. Strong ability in negotiation and conflict resolution and aligning divergent priorities to enterprise outcomes and enforces clear responsibilities. Demonstrated ability to drive large-scale change, embed innovation, and lead continuous improvement initiatives, while ensuring adoption of standardized, risk-based, and digital practices. Demonstrated disciplined prioritization focused on critical metrics and high-value initiatives. Highly adaptable and resilient under pressure, exercising sound judgment and initiative while maintaining alignment with organizational priorities. Ability to develop leaders with broad business context, accountability, and execution excellence. Champions change, continuous improvement and innovation, while ensuring adoption of standardized, risk-based, and digital practices. 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. Qualifications: Bachelor's Degree in Life science, Data or Information technology with 15 years of experience in data management, including: 10 years of people management experience Demonstrated experience in clinical data management, clinical trial operations, and managing large global teams OR Advanced Degree (Masters or Doctorate) in Life Science, Data, Information Technology, Project Management or Business with 13 years of experience in data management, including: 10 years of people management experience (direct or matrix) Demonstrated experience in clinical data management, clinical trial operations, and managing large global teams clinicaltrialjobs EligibleforERP Required Skills: Budget Management, Clinical Data Management, Clinical Operations, Clinical Study Protocols, Clinical Trial Management, Clinical Trials, Clinical Trials Operations, Cross-Functional Leadership, Data Processing, Data Validation, Executive Leadership, Good Clinical Practice (GCP), Strategic Direction, Strategic Leadership Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $231,900.00 - $365,000.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at . You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. 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 Search Firm Representatives Please Read Carefully- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.- Employee Status: Regular Relocation: Domestic/International VISA Sponsorship: Yes Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/27/2026 *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. Requisition ID: R398611 #J-18808-Ljbffr Merck & Co.