Associate Director, Clinical Data Management

MSD

. Provide program-level oversight of data standards for Global Data Management and Standards .

Posted 10/23/2026full-timeUnited StatesSenior💰 $142,400 - $224,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical data standards development and implementation, particularly with CDISC standards such as CDASH and SDTM. Proven ability to lead cross-functional teams, mentor staff, and drive compliance with regulatory requirements in clinical data management.

Highest-signal resume keywords

Clinical Data Standards DevelopmentCDISC Standards ExpertiseElectronic Data CaptureLeadership and MentoringRegulatory Compliance Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Data ManagementData Collection DefinitionsData ModelingControlled TerminologySDTMCDASHData AnalysisStudy Protocol InterpretationQuality ComplianceContinuous Improvement

Soft Skills

Strong CommunicationCollaborationOrganizationPrioritizationInfluence and Motivation

Tools & Technologies

EDC SystemsData Standards LibrariesSOPsWork InstructionsGovernance Teams

Industry Keywords

Clinical DevelopmentDrug Discovery ProcessICH GuidelinesGCP GuidelinesRegulatory Data Management

About the role

Key responsibilities & impact

Provide program-level oversight of data standards for Global Data Management and Standards
Guide study teams on standards library use and first-line governance
Advance new and modified standards and business processes
Lead Therapeutic Area Standards Teams (TASTs), training, information governance, conformance and benefits tracking, and mentoring
Define and maintain standardized EDC and non-EDC data collection definitions aligned with CDISC, health authority regulations, and clinical lifecycle needs
Lead or participate in organizational initiatives
Support audits and inspections
Support information governance reviews through TAST and SLIC governance teams
Develop and deliver standards training and best practices to cross-functional teams
Participate in training development, delivery, and mentoring for Global Clinical Data Standards staff
Engage in industry forums, maintain professional networks, and influence clinical data standards direction
Identify technology, industry standards, and regulatory trends and assess impacts on company standards
Partner with GDMS and cross-functional teams to align priorities and close feedback loops
Provide therapeutic-area oversight and expertise in data collection, transformation design, and data modeling
Serve on core study design teams and provide governance for library form changes and new content
Support future standards libraries and review SOPs, work instructions, and processes for quality compliance
Participate in operational and study team forums
Support data collection functional-area processes and related technologies

Requirements

What you’ll need

Associate’s degree and a minimum of 15 years’ clinical data management or standards experience (or related discipline), OR bachelor’s degree and a minimum of 8 years’ experience, OR advanced degree (master’s or doctorate) and a minimum of 4 years’ experience
Expertise in clinical data standards development and implementation
Deep knowledge and experience applying CDISC standards, including CDASH, Controlled Terminology, and SDTM
Deep understanding and experience with clinical development trial processes, data management, and worldwide regulatory data management and reporting requirements
Understanding of program-level clinical and business requirements and standards impact
Knowledge of the Drug Discovery Process, ICH, and GCP guidelines
Knowledge in at least one therapeutic area and ability to drive consistency across studies
Knowledge of analysis and reporting
Expertise in electronic data capture and external supplier data
Ability to apply enterprise-wide study needs across Controlled Terminology, SDTM, analysis, reporting, and submission deliverables
Ability to interpret study protocols and translate requirements into compliant data standard definitions
Strong communication and collaboration across cross-functional and global teams
Strong organization and prioritization skills
Ability to lead through influence and motivate geographically diverse teams
Sound judgment, accountability, escalation management, RCA/CAPA knowledge where applicable
Leadership presence, mentoring, and coaching abilities
Continuous improvement mindset and ability to drive standardized ways of working
No visa sponsorship

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, vision healthcare and other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Relocation: No relocation