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MSD

Senior Director, Clinical Data Management

MSD

. Serve on the GCDS Leadership Team to set strategy and oversee standards delivery framework, governance, and operations .

Posted 10/23/2026full-timeUnited StatesSenior💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates extensive expertise in Clinical Data Management, including governance of clinical information standards and metadata management. Proven ability to lead teams, manage stakeholder relationships, and drive strategic initiatives across therapeutic areas.

Highest-signal resume keywords
Clinical Data ManagementClinical Data Standards DevelopmentPeople ManagementStakeholder ManagementRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Controlled TerminologiesCDISCCDASHSDTMADaMHL7Data Transformation DesignData ModelingElectronic Data CaptureAnalysis and Reporting
Soft Skills
Exceptional CommunicationCollaborationStrategic LeadershipNegotiationChange Leadership
Industry Keywords
Clinical Development Trial ProcessesICH GuidelinesGCP GuidelinesTherapeutic AreasGovernance Framework

About the role

Key responsibilities & impact
  • Serve on the GCDS Leadership Team to set strategy and oversee standards delivery framework, governance, and operations
  • Drive enterprise metrics and outcomes, act as a governance escalation point, represent the company externally, and lead people management
  • Oversee teams defining and maintaining standard data collection definitions aligned with industry standards and Health Authority regulations
  • Lead or participate in organizational initiatives, strategic projects, governance forums, and reviews
  • Support audits and inspections
  • Manage timely delivery of standards and governance deliverables across GCDS sub-units
  • Coordinate resource forecasting, process optimization, operations reviews, and strategic innovation initiatives
  • Direct Standards training, best practices, training materials, mentoring, and development of the Global Clinical Data Standards team
  • Build senior stakeholder networks across GDMS, GCTO, GCD, and strategic partners; broker decisions and remove systemic blockers
  • Provide oversight for data collection/data transformation design and data modeling across therapeutic areas
  • Oversee development of future standards libraries and new or modified processes
  • Develop strategic direction for processes and tools supporting clinical data standards and information management
  • Communicate implementation plans and metrics to cross-functional stakeholders and executive leadership
  • Prioritize and oversee standards metrics, Book of Business, functional programs, projects, and governance demands
  • Act as an escalation point for study-level design and governance decisions
  • Define strategic direction and prioritization for data collection libraries and associated components
  • Set objectives, assign work, conduct reviews, coach performance, develop career plans, recruit and hire, manage employee relations, coordinate resources, manage budgets, and provide leadership updates

Requirements

What you’ll need
  • Bachelor’s Degree and minimum of 13 years' experience in Clinical Data Management or related discipline, including 3 years in clinical data standards development or metadata management
  • OR Advanced Degree (Masters or Doctorate) and minimum of 10 years' experience in Clinical Data Management or related discipline, including 3 years in clinical data standards development or metadata management
  • Minimum of 5 years people management experience (direct or matrix)
  • Demonstrated deep subject matter expertise
  • Extensive experience managing and governing clinical information standards and related activities
  • Deep knowledge of Controlled Terminologies, CDISC, CDASH, SDTM, ADaM, HL7, SDRG, ADRG, and Define.xml
  • Deep understanding of clinical development trial processes, clinical data management, and worldwide regulatory data management and reporting requirements
  • Understanding of program-level clinical and business requirements and standards impact
  • Strong knowledge of the Drug Discovery Process, ICH, and GCP guidelines
  • Advanced knowledge across multiple (>2) therapeutic areas
  • Knowledge of analysis and reporting
  • Electronic Data Capture and external supplier data expertise
  • Ability to interpret study protocols and translate requirements into compliant data standard definitions
  • Exceptional communication and collaboration across cross-functional and global teams
  • Strategic leadership, stakeholder management, negotiation, change leadership, and operational excellence capabilities
  • Ability to recruit, retain, and plan resourcing across regions and sourcing models
  • No visa sponsorship

Benefits

Comp & perks
  • Annual bonus and long-term incentive, if applicable
  • Medical, dental, and vision healthcare
  • Other insurance benefits for employee and family
  • Retirement benefits, including 401(k)
  • Paid holidays
  • Vacation
  • Compassionate days
  • Sick days
  • Hybrid work arrangement
  • No relocation required