Director, Clinical Data Management Indication Lead, Late Oncology
Merck
August 19, 2026
On-site
North Wales, PA
Clinical Research and Development
Responsibilities:
- Own day-to-day therapeutic area (TA) delivery; ensure high-quality, on-time study/program outputs across data modalities/tools (eCRF, labs, biomarkers, eCOA, imaging, EDC, etc.).
- Primary operational link among TA Leads, Program Leads, and Functional Area Geo Leaders; coordinate readiness for milestones (First Site Ready, First Patient Enrolled, database lock).
- Support acquisitions/partnerships/due diligence for operational continuity and data readiness.
- Track TA book of business and demand; initiate appropriate resourcing and balance workload/capacity across studies/geographies.
- Monitor performance metrics (data currency, query aging, lock timeliness); lead TA risk reviews and trigger CAPAs with follow-through.
- Drive consistent use of GDMS standards/tools/processes; ensure SOP, ICH-GCP, protocol, and regulatory adherence.
- Ensure documentation completeness/consistency; support audits/inspections; represent TA in governance forums (e.g., TAST, TA DRC).
- Promote collaboration/continuous improvement; support onboarding/training.
- Set objectives, coach/review performance, develop career plans, lead recruiting/hiring, and manage employee relations with HR.
- Coordinate on-shore/off-shore/contingent resources; manage operating budget and optimize spend; provide decision-ready status updates.
Technical Skills:
- Lead end-to-end clinical data management (database design/build, UAT, edit checks/validation, review/reconciliation, database lock).
- Author/validate/maintain data management deliverables for accuracy/auditability/inspection readiness.
- Understand data structures/integrations and data flow across EDC and connected systems (labs, IRT, eCOA, imaging); triage/resolve study-level issues.
- Clinical Data Manager platforms (EDC, query management, reconciliation/integration, data visualization).
- CDISC standards (CDASH, SDTM, Define-XML), metadata and controlled terminologies (e.g., LOINC).
- Knowledge of SOPs, ICH-GCP, 21 CFR Part 11/Annex 11, privacy expectations, and RBQM.
Qualifications:
- BA/BS in Nursing, Pharmacy, Life Sciences, Allied Health, Data/IT, or Medical Technology with 10 years clinical data management/clinical trial operations (incl. 3 years people management), OR BA/BS in any field with 15 years (incl. 3 years people management), OR Advanced Degree (preferred) with 8 years (incl. 3 years people management), OR Advanced Degree (preferred) with 13 years (incl. 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 instructions:
- Current employees apply HERE; current contingent workers apply HERE.
- Own day-to-day therapeutic area (TA) delivery; ensure high-quality, on-time study/program outputs across data modalities/tools (eCRF, labs, biomarkers, eCOA, imaging, EDC, etc.).
- Primary operational link among TA Leads, Program Leads, and Functional Area Geo Leaders; coordinate readiness for milestones (First Site Ready, First Patient Enrolled, database lock).
- Support acquisitions/partnerships/due diligence for operational continuity and data readiness.
- Track TA book of business and demand; initiate appropriate resourcing and balance workload/capacity across studies/geographies.
- Monitor performance metrics (data currency, query aging, lock timeliness); lead TA risk reviews and trigger CAPAs with follow-through.
- Drive consistent use of GDMS standards/tools/processes; ensure SOP, ICH-GCP, protocol, and regulatory adherence.
- Ensure documentation completeness/consistency; support audits/inspections; represent TA in governance forums (e.g., TAST, TA DRC).
- Promote collaboration/continuous improvement; support onboarding/training.
- Set objectives, coach/review performance, develop career plans, lead recruiting/hiring, and manage employee relations with HR.
- Coordinate on-shore/off-shore/contingent resources; manage operating budget and optimize spend; provide decision-ready status updates.
Technical Skills:
- Lead end-to-end clinical data management (database design/build, UAT, edit checks/validation, review/reconciliation, database lock).
- Author/validate/maintain data management deliverables for accuracy/auditability/inspection readiness.
- Understand data structures/integrations and data flow across EDC and connected systems (labs, IRT, eCOA, imaging); triage/resolve study-level issues.
- Clinical Data Manager platforms (EDC, query management, reconciliation/integration, data visualization).
- CDISC standards (CDASH, SDTM, Define-XML), metadata and controlled terminologies (e.g., LOINC).
- Knowledge of SOPs, ICH-GCP, 21 CFR Part 11/Annex 11, privacy expectations, and RBQM.
Qualifications:
- BA/BS in Nursing, Pharmacy, Life Sciences, Allied Health, Data/IT, or Medical Technology with 10 years clinical data management/clinical trial operations (incl. 3 years people management), OR BA/BS in any field with 15 years (incl. 3 years people management), OR Advanced Degree (preferred) with 8 years (incl. 3 years people management), OR Advanced Degree (preferred) with 13 years (incl. 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 instructions:
- Current employees apply HERE; current contingent workers apply HERE.