Director, Functional Area Geography Lead, Clinical 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 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. 
• 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 

• Bachelor's 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 

• Bachelor's 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:

Adaptability, Adaptability, Budget Management, Capacity Management, Clinical Data Management, Clinical Trials, Cross-Functional Collaboration, Data Validation, Decision Making, eCRF, Ethical Standards, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Mentoring Staff, Metadata Management, Operational Decisions, Organizational Performance Management, People Leadership, People Management, Performance Dashboards, Stakeholder Engagement, Strategic Leadership, Strategic Thinking, Study Data Tabulation Model (SDTM), Team Leadership {+ 1 more}

Preferred Skills:

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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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

08/22/2026

*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.