Director, Functional Area Geography Lead, Clinical Data Management

About this role

Responsibilities

• Strategic Leadership & Geographic Strategy
• Define and execute the functional area's regional operating model and multi-year optimization strategy aligned with GDMS and organizational priorities.
• Provide strategic direction, ensuring consistent execution, quality, compliance, and achievement of regional objectives.
• Partner with cross-functional stakeholders, enterprise support functions, and non-GDMS organizations to deliver strategic and operational goals.
• Communicate risks, trade-offs, and recommendations to senior leadership and governance forums.
• Champion innovation, automation, digital transformation, and risk-based data-management practices.
• Expand regional capabilities in line with business needs, industry trends, and technology-deployment principles.
• Promote knowledge sharing, continuous improvement, and alignment across geographies.
• Operational Excellence & Governance
• Drive compliant, inspection-ready, decision-quality data products and processes supporting regulatory, clinical, and operational milestones.
• Ensure adherence to regional and global processes, quality standards, privacy requirements, and system validation expectations.
• Monitor performance metrics and operational trends to improve quality, efficiency, and engagement.
• Lead regional risk, issue escalation, and capacity-management processes.
• Collaborate with Portfolio & Resource Operations to forecast resource needs, optimize capacity, and implement performance dashboards.
• Resolve resourcing and operational bottlenecks while maintaining portfolio transparency and delivery excellence.
• Provide concise and actionable updates to leadership and cross-functional stakeholders.
• Lead or contribute to global initiatives focused on capability development, standardization, and continuous improvement.
• Ensure compliance with local regulatory, labor, and business requirements.
• People Leadership & Talent Development
• Build high-performing teams through clear goal setting, prioritization, accountability, and sustainable workload management.
• Conduct performance reviews, provide coaching and recognition, and address performance concerns in partnership with HR.
• Develop talent through career planning, mentoring, succession planning, and promotion readiness.
• Lead recruiting, hiring, workforce planning, and management of contingent, on-shore, and off-shore resources.
• Foster inclusion, collaboration, knowledge sharing, and a strong culture of continuous learning.
• Manage operating budgets and ensure efficient allocation of resources against business priorities.
• Inspire and empower employees by providing clarity, support, and growth opportunities.
• Qualifications, Skills & Experience
• Technical Expertise
• Strong understanding of operational metrics, performance management frameworks, quality oversight, and service-provider management.
• Knowledge of inspection readiness, audit processes, privacy regulations, system validation, and global requirements including 21 CFR Part 11.
• Advanced analytical and forecasting capabilities using dashboards, capacity models, and performance data.
• Experience establishing standards for data integration, scalability, reuse, and operational consistency.
• Demonstrated success implementing digital, automated, and risk-based operational practices.
• Strong financial leadership including budget ownership, workforce planning, cost modeling, and value realization.
• Proven ability to lead large-scale transformation, innovation, and continuous improvement initiatives.
• Proficiency with workforce planning and resourcing tools and continuous improvement methodologies.
• Clinical Data Management Expertise
• Deep knowledge of end-to-end clinical data-management processes and the clinical trial lifecycle.
• Strong understanding of ICH-GCP requirements and their application to clinical data management.
• Expertise in vendor strategy, ecosystem management, SLA/SOW development, performance oversight, and contract risk management.
• Experience with data standards, study start-up systems, data flow processes, and quality frameworks within GDMS and GCTO.
• Proven ability to lead high-quality clinical data collection, validation, and delivery aligned to protocol requirements.
• Leadership Competencies
• Exceptional stakeholder management and collaboration skills with the ability to influence senior leaders and cross-functional teams.
• Strong communication skills with the ability to tailor messages for executive, operational, and technical audiences.
• Proven ability to lead through influence in complex, matrixed environments.
• Highly adaptable, resilient, and able to make sound decisions under pressure.
• Demonstrated success building and leading diverse, globally distributed teams.
• Strong coaching, talent-development, succession-planning, and organizational capability-building experience.
• Fluent English communication skills, both written and verbal.
• Enterprise Leadership Expectations
• Execution Excellence:
• Delivers consistent, high-quality outcomes through KPI-driven management and operational discipline.
• Strategic Planning:
• Aligns stakeholders around priorities and drives execution through influence and collaboration.
• Networking & Partnerships:
• Builds and maintains strategic internal and external relationships that advance business objectives.
• Education & Experience
• One of the following is required:
• Bachelor's degree
• in Life Sciences, Data Science, Information Technology, or related field with
• 10+ years
• of relevant experience, including
• 3+ years of people leadership
• , OR
• Bachelor's degree
• in another discipline with
• 15+ years
• of relevant experience, including
• 3+ years of people leadership
• , OR
• Master's or Doctoral degree
• in Life Sciences, Data Science, Information Technology, Project Management, Business, or related field with
• 8+ years
• of relevant experience, including
• 3+ years of people leadership
• , OR
• Master's or Doctoral degree
• in another discipline with
• 13+ years
• of relevant experience, including
• 3+ years of people leadership
• .
• All candidates must demonstrate significant experience in clinical data management, clinical trial operations, and leadership of large, globally distributed teams.
• 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