Director, Functional Area Geography Lead, External Data Management

About this role

Responsibilities

• Strategic Leadership & Geographic Management
• Define and execute the functional area's strategy, operating model, and multi-year optimization roadmap within the assigned geography, aligned with GDMS and enterprise priorities.
• Lead cross-functional partnerships with internal stakeholders and support functions to achieve regional objectives.
• Communicate risks, trade-offs, and recommendations to senior leadership while promoting innovation, automation, and risk-based data management practices.
• Identify opportunities to expand capabilities, adopt industry best practices, and implement new technologies across relevant organizations.
• Ensure consistent execution, quality, compliance, and operational excellence across the region.
• Operational Governance & Execution
• Drive delivery of compliant, high-quality, decision-ready data and processes supporting clinical, regulatory, and operational milestones.
• Maintain inspection readiness and ensure adherence to global and local quality, regulatory, privacy, and system validation requirements.
• Oversee regional risk, escalation, capacity, and resource management processes.
• Analyze operational and performance trends to improve efficiency, quality, and employee engagement.
• Partner with resource and portfolio teams to forecast demand, optimize capacity, and implement performance dashboards.
• Provide clear operational updates and serve as the primary escalation point for regional issues.
• Lead and contribute to global initiatives focused on continuous improvement and capability development.
• People Leadership & Talent Development
• Set clear goals, priorities, and performance expectations aligned with organizational objectives.
• Lead recruiting, onboarding, performance management, succession planning, and talent development activities.
• Coach, mentor, and develop team members through regular feedback, career planning, recognition, and growth opportunities.
• Foster an inclusive, collaborative, and high-performance culture across globally distributed teams.
• Manage workforce planning, contingent resources, and operating budgets to support business priorities.
• Qualifications, Skills & Experience
• Technical Expertise
• Strong knowledge of clinical data management, clinical trial operations, and the clinical development lifecycle.
• Expertise in ICH-GCP guidelines, regulatory requirements, inspection readiness, and 21 CFR Part 11.
• Experience implementing risk-based, digital, and automated data management practices.
• Advanced analytical, forecasting, capacity planning, and dashboard reporting capabilities.
• Knowledge of data standards, data governance, system validation, privacy requirements, and study start-up processes.
• Experience managing vendors, SLAs, SOWs, performance metrics, and contract risks.
• Proven ability to drive organizational change, innovation, standardization, and continuous improvement.
• Demonstrated financial acumen, including budget ownership, workforce planning, and investment management.
• CDM-Specific Technical Expertise
• Deep expertise in end-to-end clinical data management, clinical trial operations, and the clinical development lifecycle.
• Strong knowledge of ICH-GCP guidelines, regulatory requirements, clinical data standards, and quality frameworks.
• Proven experience leading risk-based data management strategies, vendor oversight, and outsourced delivery models.
• Experience with data governance, study start-up systems, data flows, and clinical technology platforms.
• Demonstrated ability to design, validate, and deliver high-quality clinical data in support of regulatory submissions and business objectives.
• Leadership & Interpersonal Skills
• Strong stakeholder management, collaboration, and influencing skills across all organizational levels.
• Ability to lead cross-functional and virtual teams without direct authority.
• Excellent judgment, problem-solving, and decision-making skills in complex environments.
• Demonstrated success building, developing, and leading high-performing global teams.
• Excellent written and verbal English communication skills.
• Strong coaching, talent development, and performance management capabilities.
• Enterprise Leadership Competencies
• Execution Excellence:
• Delivers high-quality, KPI-driven outcomes and continuous performance improvement.
• Strategic Planning:
• Aligns regional strategy with organizational priorities and drives execution through influence.
• Networking & Partnerships:
• Builds effective internal and external relationships to advance business objectives.
• Leadership & Professional Skills
• Strong stakeholder management and ability to influence senior leaders and cross-functional teams.
• Proven success leading, developing, and retaining high-performing global teams.
• Excellent coaching, talent development, succession planning, and performance management capabilities.
• Strong business acumen, decision-making, problem-solving, and organizational leadership skills.
• Highly adaptable and effective in complex, fast-paced, and evolving environments.
• Excellent written and verbal communication skills in English.
• Qualifications & Experience
• Bachelor's degree with
• 10+ years
• of relevant data management experience, or an Advanced Degree with
• 8+ years
• of relevant experience.
• 3+ years of people management experience.
• Demonstrated expertise in clinical data management and clinical trial operations.
• Proven success leading large, globally distributed teams and complex cross-functional initiatives.
• Required Skills:
• Adaptability, Adaptability, Budget 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), Inspection Readiness, Labor Compliance, Mentoring Staff, Metadata Management, Operational Decisions, Organizational Performance Management, People Leadership, Performance Dashboards, Strategic Collaborations, Strategic Thinking, Study Data Tabulation Model (SDTM), Talent Management, Team Leadership {+ 1 more}
• Preferred Skills:
• Current Employees apply
• HERE
• Current Contingent Workers apply
• HERE
• 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