Senior Director, Clinical Data Management, Therapeutic Area Lead, Hematology
Merck
August 19, 2026
On-site
Rahway, NJ
Clinical Research and Development
Responsibilities
- Own TA portfolio strategy/prioritization; develop TA roadmap and study sequencing; balance resources, timelines, and risks.
- Ensure seamless global CDM delivery with risk-based, quality-by-design execution across in-scope data modalities.
- Embed standards, automation, and data-integration practices into TA operating models; define requirements; drive tool adoption; establish TA dashboards/KPIs; scale automation pilots.
- Forecast capability/capacity by region and program; optimize onshore/offshore/contingent models.
- Lead TA-wide quality governance, inspection readiness, and risk management; harmonize CAPA tracking; present performance and corrective actions.
- Escalation point for complex issues; capture/scale lessons learned; partner on enterprise transformation (process/standards/platform tools) aligned to digital/data/regulatory guardrails.
- Lead people and team operations: set objectives, coach, develop career plans, recruit/hire.
- Manage operating budget and optimize spend; align teams; provide decision-ready status updates.
Global Capability Leadership (as assigned)
- Represent capability on CDM leadership team; lead capability development roadmap, governance, and global rollout via playbooks/guidance.
Technical/Non-Technical Skills (high level)
- End-to-end clinical data management (e.g., database design/build/UAT, validation, reconciliation, lock).
- Expertise in EDC and integrations (labs, IRT, eCOA, imaging); CDISC (CDASH/SDTM/Define-XML), metadata and controlled terminologies; SOPs/ICH-GCP/21 CFR Part 11/Annex 11; RBQM.
- Strategic and people leadership; stakeholder management; change leadership.
Qualifications
- BA/BS in relevant field + 13 years clinical data management/clinical trial ops (incl. 5 yrs people management) OR BA/BS any field + 18 years (incl. 5 yrs people management) OR Master/Doctorate (preferred) + 10 years (incl. 5 yrs people management).
- Demonstrated experience leading geographically diverse cross-functional teams and delivering strategy/execution/submissions.
Required Skills
- Change management; clinical data standards; clinical trials operations; cross-functional teamwork; data governance; decision making; GCP; oncology; people leadership; stakeholder relationship management; strategic planning.
Preferred Skills
- Adaptability; operational execution; strategic thinking.
Compensation/Benefits (as stated)
- Salary range: $173,200–$272,600; eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, and sick/compassionate days).
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting; Job posting end date: 08/30/2026 (apply by 11:59:59PM the day before).
- Own TA portfolio strategy/prioritization; develop TA roadmap and study sequencing; balance resources, timelines, and risks.
- Ensure seamless global CDM delivery with risk-based, quality-by-design execution across in-scope data modalities.
- Embed standards, automation, and data-integration practices into TA operating models; define requirements; drive tool adoption; establish TA dashboards/KPIs; scale automation pilots.
- Forecast capability/capacity by region and program; optimize onshore/offshore/contingent models.
- Lead TA-wide quality governance, inspection readiness, and risk management; harmonize CAPA tracking; present performance and corrective actions.
- Escalation point for complex issues; capture/scale lessons learned; partner on enterprise transformation (process/standards/platform tools) aligned to digital/data/regulatory guardrails.
- Lead people and team operations: set objectives, coach, develop career plans, recruit/hire.
- Manage operating budget and optimize spend; align teams; provide decision-ready status updates.
Global Capability Leadership (as assigned)
- Represent capability on CDM leadership team; lead capability development roadmap, governance, and global rollout via playbooks/guidance.
Technical/Non-Technical Skills (high level)
- End-to-end clinical data management (e.g., database design/build/UAT, validation, reconciliation, lock).
- Expertise in EDC and integrations (labs, IRT, eCOA, imaging); CDISC (CDASH/SDTM/Define-XML), metadata and controlled terminologies; SOPs/ICH-GCP/21 CFR Part 11/Annex 11; RBQM.
- Strategic and people leadership; stakeholder management; change leadership.
Qualifications
- BA/BS in relevant field + 13 years clinical data management/clinical trial ops (incl. 5 yrs people management) OR BA/BS any field + 18 years (incl. 5 yrs people management) OR Master/Doctorate (preferred) + 10 years (incl. 5 yrs people management).
- Demonstrated experience leading geographically diverse cross-functional teams and delivering strategy/execution/submissions.
Required Skills
- Change management; clinical data standards; clinical trials operations; cross-functional teamwork; data governance; decision making; GCP; oncology; people leadership; stakeholder relationship management; strategic planning.
Preferred Skills
- Adaptability; operational execution; strategic thinking.
Compensation/Benefits (as stated)
- Salary range: $173,200–$272,600; eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, and sick/compassionate days).
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting; Job posting end date: 08/30/2026 (apply by 11:59:59PM the day before).