Associate Director - External Data Acquisition Lead (EDAL)
Genmab
August 16, 2026
Remote friendly (United States)
United States
Operations
The Associate Director, External Data Acquisition Lead (EDAL) role is a clinical data manager responsible for data collection from external providers (e.g., laboratories, eCOA, technology providers). Provides oversight of external clinical data integration processes and data quality, serves as subject matter expert for external data management for clinical trial teams, and ensures end-to-end Data Management activities/deliverables for external data.
Responsibilities:
- Lead external data acquisition across studies/programs; ensure high-quality, timely, analysis-ready data.
- Advise on protocol/amendments for external data collection design and integration feasibility aligned with CDASH/SDTM and EDC requirements.
- Plan and oversee external data flow strategies and DTS across data types (PK/ADA, biomarker, imaging, central lab, eCOA/ePRO, PD, IRT, etc.).
- Partner cross-functionally to support operational and scientific goals.
- Develop/manage Trial Data Integrity Plans (TDIP) and Data Flow.
- Create/maintain DTS requirements; align vendor data with clinical database and SDTM; ensure standard data formats.
- Review vendor budgets/change orders; act as escalation point for vendor issues.
- Mentor junior leads; lead SOP/process improvement/tools optimization and external data standards governance.
- Ensure vendor deliverables comply with protocol, ICH, GCP, and SOPs.
Requirements:
- BS/MS in relevant technical area; MS preferred.
- 10+ years external or clinical data management with third-party vendor oversight/data acquisition.
- Oncology trial/data experience.
- Experience designing/governing DTS and complex data flows for EDC integration and CDISC (CDASH, SDTM).
- Knowledge of external data types (biomarker, central lab, imaging, eCOA/ePRO, genomic).
- Experience managing global projects/vendors and process improvements.
Benefits (US, first year eligibility): 401(k) 100% match on first 6%; health/dental/vision; paid vacation/sick/holidays and 12 weeks paid parental leave; backup care/family support and other wellness resources; commuter/tuition/lifestyle spending account.
Responsibilities:
- Lead external data acquisition across studies/programs; ensure high-quality, timely, analysis-ready data.
- Advise on protocol/amendments for external data collection design and integration feasibility aligned with CDASH/SDTM and EDC requirements.
- Plan and oversee external data flow strategies and DTS across data types (PK/ADA, biomarker, imaging, central lab, eCOA/ePRO, PD, IRT, etc.).
- Partner cross-functionally to support operational and scientific goals.
- Develop/manage Trial Data Integrity Plans (TDIP) and Data Flow.
- Create/maintain DTS requirements; align vendor data with clinical database and SDTM; ensure standard data formats.
- Review vendor budgets/change orders; act as escalation point for vendor issues.
- Mentor junior leads; lead SOP/process improvement/tools optimization and external data standards governance.
- Ensure vendor deliverables comply with protocol, ICH, GCP, and SOPs.
Requirements:
- BS/MS in relevant technical area; MS preferred.
- 10+ years external or clinical data management with third-party vendor oversight/data acquisition.
- Oncology trial/data experience.
- Experience designing/governing DTS and complex data flows for EDC integration and CDISC (CDASH, SDTM).
- Knowledge of external data types (biomarker, central lab, imaging, eCOA/ePRO, genomic).
- Experience managing global projects/vendors and process improvements.
Benefits (US, first year eligibility): 401(k) 100% match on first 6%; health/dental/vision; paid vacation/sick/holidays and 12 weeks paid parental leave; backup care/family support and other wellness resources; commuter/tuition/lifestyle spending account.