Director, Clinical Data Management Indication Lead, Late Oncology
Merck
August 14, 2026
On-site
Rahway, NJ
Clinical Research and Development
Responsibilities:
- Provide operational leadership for clinical data management delivery within assigned indication(s) and therapeutic area; ensure timely, compliant, high-quality study/program data across data modalities/tools (eCRF, labs, biomarkers, eCOA, imaging, EDC, etc.).
- Own day-to-day TA portfolio execution; manage resources, workload/capacity across studies and geographies; coordinate readiness for milestones (site ready, first patient enrolled, database lock).
- Serve as operational link among TA Leads, Program Leads, and functional geo leaders; support acquisitions/partnerships/due diligence as needed.
- Track TA book of business/demand; monitor performance metrics (data currency, query aging, lock timeliness).
- Lead TA-level risk reviews; trigger CAPAs and ensure follow-through.
- Drive consistent use of GDMS standards/tools/processes and ensure SOP/ICH-GCP/protocol/regulatory adherence.
- Ensure documentation completeness/consistency; support audits/inspections.
- Represent TA in governance forums (e.g., TAST, TA DRC); promote collaboration, standardization, onboarding/training, and continuous improvement.
- Set objectives, assign work/priorities; coach, develop, recruit/hire; manage budget and updates to leadership/partners.
Technical skills:
- End-to-end clinical data management leadership (DB design/build, UAT, edit checks/validation, review/reconciliation, database lock).
- CDISC (CDASH, SDTM, Define-XML), metadata/controlled terminology; strong SOPs, ICH-GCP, 21 CFR Part 11/Annex 11, privacy expectations; RBQM.
Qualifications:
- BS/BA (or equivalent) with 10 years relevant experience incl. 3 years people management; OR BS/BA with 15 years incl. 3 years people management; OR Advanced Degree (preferred) with 8 years (or 13 years if non-listed field), including 3 years people management.
- Demonstrated experience leading geo-different cross-functional teams delivering clinical data management/operations strategy, execution, and submissions.
Required skills: Change management; clinical data standards; clinical trials operations; cross-functional teamwork; data governance; decision making; ethical standards; GCP; oncology; people leadership; stakeholder relationship management; strategic planning.
Preferred skills: Adaptability; operational execution; strategic thinking.
Application:
- Apply via https://jobs.merck.com/us/en. Application deadline is stated on the posting.
- Provide operational leadership for clinical data management delivery within assigned indication(s) and therapeutic area; ensure timely, compliant, high-quality study/program data across data modalities/tools (eCRF, labs, biomarkers, eCOA, imaging, EDC, etc.).
- Own day-to-day TA portfolio execution; manage resources, workload/capacity across studies and geographies; coordinate readiness for milestones (site ready, first patient enrolled, database lock).
- Serve as operational link among TA Leads, Program Leads, and functional geo leaders; support acquisitions/partnerships/due diligence as needed.
- Track TA book of business/demand; monitor performance metrics (data currency, query aging, lock timeliness).
- Lead TA-level risk reviews; trigger CAPAs and ensure follow-through.
- Drive consistent use of GDMS standards/tools/processes and ensure SOP/ICH-GCP/protocol/regulatory adherence.
- Ensure documentation completeness/consistency; support audits/inspections.
- Represent TA in governance forums (e.g., TAST, TA DRC); promote collaboration, standardization, onboarding/training, and continuous improvement.
- Set objectives, assign work/priorities; coach, develop, recruit/hire; manage budget and updates to leadership/partners.
Technical skills:
- End-to-end clinical data management leadership (DB design/build, UAT, edit checks/validation, review/reconciliation, database lock).
- CDISC (CDASH, SDTM, Define-XML), metadata/controlled terminology; strong SOPs, ICH-GCP, 21 CFR Part 11/Annex 11, privacy expectations; RBQM.
Qualifications:
- BS/BA (or equivalent) with 10 years relevant experience incl. 3 years people management; OR BS/BA with 15 years incl. 3 years people management; OR Advanced Degree (preferred) with 8 years (or 13 years if non-listed field), including 3 years people management.
- Demonstrated experience leading geo-different cross-functional teams delivering clinical data management/operations strategy, execution, and submissions.
Required skills: Change management; clinical data standards; clinical trials operations; cross-functional teamwork; data governance; decision making; ethical standards; GCP; oncology; people leadership; stakeholder relationship management; strategic planning.
Preferred skills: Adaptability; operational execution; strategic thinking.
Application:
- Apply via https://jobs.merck.com/us/en. Application deadline is stated on the posting.