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Senior Manager, Clinical Data Enablement

Takeda
August 14, 2026
Remote
United States
$137,000 - $215,270 USD yearly
Operations
Responsibilities:
- Own end-to-end clinical data pipelines across lake/warehouse environments (build, run, monitor, maintain, troubleshoot).
- Drive operational excellence via monitoring/alerting, incident management, root-cause analysis, and corrective/preventive actions.
- Build and scale cloud ETL/ELT capabilities (AWS/Azure) for ingestion, transformation, orchestration, and delivery.
- Automate integrations and operations (scheduling, metadata-driven pipelines, automated quality checks).
- Define data transfer specifications, acceptance criteria, and integration patterns; implement integrations with robust error handling and reconciliation.
- Serve as an SME for structured/unstructured data integration; drive continuous improvements.
- Partner with downstream teams to deliver fit-for-purpose datasets and interfaces (format, structure, cadence).
- Ensure on-time, high-quality delivery; establish/manage SLAs/OLAs.
- Design and deliver GxP-aligned solutions with lifecycle documentation, traceability, and audit-ready evidence.
- Embed data integrity controls (e.g., ALCOA+) and support validated operations (change control, deviations, review, inspection readiness).
- Collaborate with Quality/Compliance/IT on access controls and logging/audit trails (as applicable).

Qualifications/Experience:
- BS/BA or equivalent + 6+ years in data engineering/pipeline operations and multi-source clinical/biopharma integration.
- Strong SQL, data modeling, and data quality controls; working knowledge of NoSQL.
- Proficiency in Python (preferred) or R; production pipeline development/testing/logging/monitoring; SDLC familiarity; Jira/Confluence required.
- Knowledge of CDISC, CDASH, SDTM preferred.
- Hands-on CSV/JSON/XML and API/file-based integrations.
- Cloud experience (AWS: EC2/EMR/RDS/Redshift/Apache Spark) and/or Snowflake/Databricks; performance/maintenance of large-scale pipelines.
- GitHub/GitLab; CI/CD exposure preferred.
- GxP-regulated environment experience; ability to embed data integrity controls.
- Mentor junior engineers; strong collaboration, communication, and proactive problem-solving.

Preferred Skills/Certifications:
- Prior regulatory inspection experience; AWS/Azure and/or Python certification.

Application instructions:
- Apply via the β€œApply” button (acknowledges employment application processing per privacy notice/terms of use).