Associate Director, Clinical Data Enablement
Takeda
August 06, 2026
Remote
United States
$154,400 - $242,550 USD yearly
Operations
Associate Director, Clinical Data Enablement (Remote)
Goals/Responsibilities
- Lead end-to-end clinical data delivery and ingestion, including integration, operational monitoring, and downstream consumption.
- Deliver review-ready, reliable, traceable, compliant data into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) and enterprise data lake/warehouse ecosystems.
- Own delivery plans and execution across studies/vendor feeds; manage risks, dependencies, and release schedules.
- Establish SLAs/OLAs and track delivery KPIs and service health (timeliness, completeness, quality, incident trends).
- Build/evolve reusable metadata-driven ingestion/integration frameworks, QC rules, automation utilities, and runbooks.
- Automate operational workflows (scheduling, exception handling, automated quality checks).
- Lead design/operation of clinical data pipelines; build/scale cloud ETL/ELT (AWS/Azure).
- Define transfer specs/mappings/acceptance criteria and reconcile with vendors/stakeholders; align exports with SDTM/Stats/Analytics/CDP needs.
- Ensure GxP/CSV compliance and embed ALCOA+ data integrity controls.
- Mentor junior staff/FSPs; standardize fixes and ways of working to reduce key-person dependency.
Qualifications / Skills
- BS/BA (or equivalent) + 7+ years in data ingestion/integration, ETL/ELT operations, or clinical data pipeline support.
- Experience with Veeva CDB, Elluminate, and/or JReview (or comparable systems).
- Strong SQL; Python (preferred) for automation (ingestion/QC/parsing/ops).
- Knowledge of ingestion concepts: data contracts/specs, refresh cadence, incremental vs full loads, reprocessing, reconciliation, lineage.
- Hands-on with CSV/JSON/XML and file/API integrations; secure transfer (e.g., SFTP/MFT).
- Monitoring/alerting, incident triage, reruns, and KPI/SLA reporting.
- Working knowledge of clinical sources (EDC, CTMS, labs, eCOA/ePRO, imaging, safety); strong documentation and regulated-environment experience.
- Strong cross-functional communication and proactive problem-solving.
Compensation & Benefits (U.S. base)
- Base salary range: $154,400.00–$242,550.00. Possible eligibility for medical/dental/vision, 401(k) match, incentives, disability/life insurance, tuition reimbursement, paid vacation/sick time, and other well-being benefits.
Goals/Responsibilities
- Lead end-to-end clinical data delivery and ingestion, including integration, operational monitoring, and downstream consumption.
- Deliver review-ready, reliable, traceable, compliant data into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) and enterprise data lake/warehouse ecosystems.
- Own delivery plans and execution across studies/vendor feeds; manage risks, dependencies, and release schedules.
- Establish SLAs/OLAs and track delivery KPIs and service health (timeliness, completeness, quality, incident trends).
- Build/evolve reusable metadata-driven ingestion/integration frameworks, QC rules, automation utilities, and runbooks.
- Automate operational workflows (scheduling, exception handling, automated quality checks).
- Lead design/operation of clinical data pipelines; build/scale cloud ETL/ELT (AWS/Azure).
- Define transfer specs/mappings/acceptance criteria and reconcile with vendors/stakeholders; align exports with SDTM/Stats/Analytics/CDP needs.
- Ensure GxP/CSV compliance and embed ALCOA+ data integrity controls.
- Mentor junior staff/FSPs; standardize fixes and ways of working to reduce key-person dependency.
Qualifications / Skills
- BS/BA (or equivalent) + 7+ years in data ingestion/integration, ETL/ELT operations, or clinical data pipeline support.
- Experience with Veeva CDB, Elluminate, and/or JReview (or comparable systems).
- Strong SQL; Python (preferred) for automation (ingestion/QC/parsing/ops).
- Knowledge of ingestion concepts: data contracts/specs, refresh cadence, incremental vs full loads, reprocessing, reconciliation, lineage.
- Hands-on with CSV/JSON/XML and file/API integrations; secure transfer (e.g., SFTP/MFT).
- Monitoring/alerting, incident triage, reruns, and KPI/SLA reporting.
- Working knowledge of clinical sources (EDC, CTMS, labs, eCOA/ePRO, imaging, safety); strong documentation and regulated-environment experience.
- Strong cross-functional communication and proactive problem-solving.
Compensation & Benefits (U.S. base)
- Base salary range: $154,400.00–$242,550.00. Possible eligibility for medical/dental/vision, 401(k) match, incentives, disability/life insurance, tuition reimbursement, paid vacation/sick time, and other well-being benefits.