Senior Director Clinical Data Management
Merck
August 24, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Responsibilities
- Oversee strategy and standards delivery framework for clinical data collection (EDC and non-EDC), including definitions aligned to industry standards and Health Authority guidance.
- Own management and timely delivery of standards/governance deliverables; coordinate planning, resourcing, process optimization, operations reviews, and innovation.
- Provide oversight for standards training, best practices, training materials, delivery, and mentoring.
- Lead/participate in industry forums and governance initiatives; maintain stakeholder networks and broker decisions to remove blockers.
- Provide expertise across one or more therapeutic areas on data collection/transformation design and data modeling; ensure consistency with standards.
- Serve as escalation point for governance decisions and study-level design; oversee implementation and communication of plans.
- Prioritize and oversee standards metrics; communicate metrics to Executive Leadership; support audits/inspections.
People Management Responsibilities
- Set objectives, assign priorities, run check-ins/annual reviews, coach and recognize.
- Develop career plans, recruit/hire, manage workloads/resources (including on/off-shore), and manage an operating budget.
Technical/Required Skills & Qualifications
- Extensive experience governing clinical information standards and clinical data standards development/implementation.
- Deep knowledge applying CDISC, CDASH, SDTM, ADaM, HL7 and submission deliverables (e.g., SDRG/ADRG/Define.xml), plus clinical trial processes and worldwide regulatory DM/reporting.
- Strong knowledge of Drug Discovery, ICH and GCP; interpret protocols to translate requirements into compliant data definitions.
- Bachelor’s degree + 15 years Clinical Data Management (3 in standards/metadata; 10+ years people management) OR Master’s/Doctorate + 13 years (3 in standards/metadata; 10+ years people management).
- Required skills include client focus, clinical data/study management, conflict resolution, data processing/validation, GCP, strategic planning, and innovation.
Preferred
- ACRP-CP; experience with eCRF design, database development/validation, UAT, data extraction/transformation to SDTM, and analysis/reporting; PMP; FAIR/ALCOA knowledge; programming to generate insights.
Benefits / Incentives
- Annual bonus and long-term incentive (if applicable) and comprehensive benefits (medical/dental/vision, 401(k), paid holidays, vacation, sick/compassionate days).
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Deadline is stated on the posting.
- Oversee strategy and standards delivery framework for clinical data collection (EDC and non-EDC), including definitions aligned to industry standards and Health Authority guidance.
- Own management and timely delivery of standards/governance deliverables; coordinate planning, resourcing, process optimization, operations reviews, and innovation.
- Provide oversight for standards training, best practices, training materials, delivery, and mentoring.
- Lead/participate in industry forums and governance initiatives; maintain stakeholder networks and broker decisions to remove blockers.
- Provide expertise across one or more therapeutic areas on data collection/transformation design and data modeling; ensure consistency with standards.
- Serve as escalation point for governance decisions and study-level design; oversee implementation and communication of plans.
- Prioritize and oversee standards metrics; communicate metrics to Executive Leadership; support audits/inspections.
People Management Responsibilities
- Set objectives, assign priorities, run check-ins/annual reviews, coach and recognize.
- Develop career plans, recruit/hire, manage workloads/resources (including on/off-shore), and manage an operating budget.
Technical/Required Skills & Qualifications
- Extensive experience governing clinical information standards and clinical data standards development/implementation.
- Deep knowledge applying CDISC, CDASH, SDTM, ADaM, HL7 and submission deliverables (e.g., SDRG/ADRG/Define.xml), plus clinical trial processes and worldwide regulatory DM/reporting.
- Strong knowledge of Drug Discovery, ICH and GCP; interpret protocols to translate requirements into compliant data definitions.
- Bachelor’s degree + 15 years Clinical Data Management (3 in standards/metadata; 10+ years people management) OR Master’s/Doctorate + 13 years (3 in standards/metadata; 10+ years people management).
- Required skills include client focus, clinical data/study management, conflict resolution, data processing/validation, GCP, strategic planning, and innovation.
Preferred
- ACRP-CP; experience with eCRF design, database development/validation, UAT, data extraction/transformation to SDTM, and analysis/reporting; PMP; FAIR/ALCOA knowledge; programming to generate insights.
Benefits / Incentives
- Annual bonus and long-term incentive (if applicable) and comprehensive benefits (medical/dental/vision, 401(k), paid holidays, vacation, sick/compassionate days).
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Deadline is stated on the posting.