Senior Director Clinical Data Management
Merck
August 24, 2026
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
Responsibilities:
- Set strategy and oversee clinical data collection standards delivery, governance, and operations (planning, resourcing, process excellence, innovation).
- Provide oversight for standard data collection definitions (EDC and non-EDC) aligned to CDISC and Health Authority guidance; support audits/inspections.
- Accountable for timely delivery of standards/governance deliverables across sub-units; coordinate training/best practices and mentoring.
- Lead industry forums and stakeholder networks; broker decisions, remove blockers, and serve as escalation point for governance and study-level design.
- Provide oversight of data collection/data transformation design and data modeling consistency (TAs); drive standards metrics and communicate to executive leadership.
People Management Responsibilities:
- Set objectives, assign priorities; run check-ins/reviews, coach/recognize; develop career plans.
- Lead recruiting/hiring and manage employee relations with HR; manage budgets and resourcing (on/off-shore/contingent).
Technical Skills (required):
- Manage/govern clinical information standards; deep knowledge of CDISC (CDASH, SDTM, ADaM), HL7, and submission/analysis reporting deliverables (e.g., SDRG/ADRG/Define.xml).
- Clinical development trial and global regulatory DM/reporting expertise; ICH/GCP.
Qualifications:
- Bachelor’s + 15 years Clinical Data Management (or related), including 3 years standards/metadata; 10 years people management.
OR Master’s/Doctorate + 13 years (incl. same 3 years standards/metadata; 10 years people management).
Preferred:
- ACRP-CP; FAIR/ALCOA knowledge; eCRF/design, SDTM transformation, PMP.
Required Skills:
- Client-focused; clinical data/study management; conflict resolution; data processing/validation; strategic planning; GCP.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).
- Set strategy and oversee clinical data collection standards delivery, governance, and operations (planning, resourcing, process excellence, innovation).
- Provide oversight for standard data collection definitions (EDC and non-EDC) aligned to CDISC and Health Authority guidance; support audits/inspections.
- Accountable for timely delivery of standards/governance deliverables across sub-units; coordinate training/best practices and mentoring.
- Lead industry forums and stakeholder networks; broker decisions, remove blockers, and serve as escalation point for governance and study-level design.
- Provide oversight of data collection/data transformation design and data modeling consistency (TAs); drive standards metrics and communicate to executive leadership.
People Management Responsibilities:
- Set objectives, assign priorities; run check-ins/reviews, coach/recognize; develop career plans.
- Lead recruiting/hiring and manage employee relations with HR; manage budgets and resourcing (on/off-shore/contingent).
Technical Skills (required):
- Manage/govern clinical information standards; deep knowledge of CDISC (CDASH, SDTM, ADaM), HL7, and submission/analysis reporting deliverables (e.g., SDRG/ADRG/Define.xml).
- Clinical development trial and global regulatory DM/reporting expertise; ICH/GCP.
Qualifications:
- Bachelor’s + 15 years Clinical Data Management (or related), including 3 years standards/metadata; 10 years people management.
OR Master’s/Doctorate + 13 years (incl. same 3 years standards/metadata; 10 years people management).
Preferred:
- ACRP-CP; FAIR/ALCOA knowledge; eCRF/design, SDTM transformation, PMP.
Required Skills:
- Client-focused; clinical data/study management; conflict resolution; data processing/validation; strategic planning; GCP.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).