Associate Director, Clinical Data Enablement
Takeda
August 06, 2026
Remote
United States
$154,400 - $242,550 USD yearly
Operations
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Associate Director, Clinical Data Enablement (Remote/Virtual, reporting to Director, Clinical Data Engineering)
Goals / Responsibilities:
- Own end-to-end clinical data delivery: ingestion, integration, operational monitoring, and downstream consumption.
- Lead delivery into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) and enterprise data lake/warehouse systems; ensure data is review-ready, reliable, traceable, and compliant.
- Define delivery plans, prioritize across concurrent studies/vendors, manage risks/dependencies/release schedules.
- Establish SLAs/OLAs, delivery KPIs, and service health reporting.
- Build reusable ingestion/integration frameworks (metadata-driven mappings, templates, QC rules, automation utilities, runbooks).
- Automate operational workflows (scheduling, exception handling, quality checks).
- Design/operate clinical data pipelines (build/run/monitor/troubleshoot).
- Build/scale cloud ETL/ELT (AWS/Azure) and provide SME troubleshooting and standardized fixes.
- Maintain transfer specs/mappings/acceptance criteria and align exports to SDTM/Stats/Analytics/CDP needs.
- Ensure GxP/CSV compliance and embed ALCOA+ data integrity controls.
- Lead/mentor FSPs and junior staff; standardize ways of working.
Qualifications / Required/Preferred Skills:
- BS/BA (or equivalent) + 7+ years in data ingestion/integration, ETL/ELT ops, or clinical data pipeline support.
- Experience with Veeva CDB, Elluminate, and/or JReview (or comparable systems).
- Strong end-to-end ingestion knowledge (data contracts, refresh cadence, incremental vs full loads, reconciliation, traceable lineage).
- Ability to design automated QC/validation for review-ready datasets.
- Hands-on CSV/JSON/XML; file- and/or API-based integrations; SFTP/managed file transfer familiarity.
- Strong SQL; Python preferred for automation.
- Monitoring/alerting for transfers/pipelines (expected vs received, incident triage, KPI/SLA reporting).
- Clinical source familiarity (e.g., EDC/CTMS; labs, eCOA/ePRO, imaging, safety).
- Strong documentation and GxP/CSV exposure.
Benefits (explicitly stated): Eligible for short-/long-term incentives and medical/dental/vision, 401(k) match, disability and life insurance, tuition reimbursement, paid volunteer time off, holidays, and well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation (new hires accrue).
Associate Director, Clinical Data Enablement (Remote/Virtual, reporting to Director, Clinical Data Engineering)
Goals / Responsibilities:
- Own end-to-end clinical data delivery: ingestion, integration, operational monitoring, and downstream consumption.
- Lead delivery into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) and enterprise data lake/warehouse systems; ensure data is review-ready, reliable, traceable, and compliant.
- Define delivery plans, prioritize across concurrent studies/vendors, manage risks/dependencies/release schedules.
- Establish SLAs/OLAs, delivery KPIs, and service health reporting.
- Build reusable ingestion/integration frameworks (metadata-driven mappings, templates, QC rules, automation utilities, runbooks).
- Automate operational workflows (scheduling, exception handling, quality checks).
- Design/operate clinical data pipelines (build/run/monitor/troubleshoot).
- Build/scale cloud ETL/ELT (AWS/Azure) and provide SME troubleshooting and standardized fixes.
- Maintain transfer specs/mappings/acceptance criteria and align exports to SDTM/Stats/Analytics/CDP needs.
- Ensure GxP/CSV compliance and embed ALCOA+ data integrity controls.
- Lead/mentor FSPs and junior staff; standardize ways of working.
Qualifications / Required/Preferred Skills:
- BS/BA (or equivalent) + 7+ years in data ingestion/integration, ETL/ELT ops, or clinical data pipeline support.
- Experience with Veeva CDB, Elluminate, and/or JReview (or comparable systems).
- Strong end-to-end ingestion knowledge (data contracts, refresh cadence, incremental vs full loads, reconciliation, traceable lineage).
- Ability to design automated QC/validation for review-ready datasets.
- Hands-on CSV/JSON/XML; file- and/or API-based integrations; SFTP/managed file transfer familiarity.
- Strong SQL; Python preferred for automation.
- Monitoring/alerting for transfers/pipelines (expected vs received, incident triage, KPI/SLA reporting).
- Clinical source familiarity (e.g., EDC/CTMS; labs, eCOA/ePRO, imaging, safety).
- Strong documentation and GxP/CSV exposure.
Benefits (explicitly stated): Eligible for short-/long-term incentives and medical/dental/vision, 401(k) match, disability and life insurance, tuition reimbursement, paid volunteer time off, holidays, and well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation (new hires accrue).