Note: The job is a remote job and is open to candidates in USA. Takeda is a patient-focused, innovation-driven pharmaceutical company transforming the industry through R&D-driven market leadership and a values-led culture. The Senior Manager, Clinical Data Enablement operates and continuously improves clinical data pipelines across cloud-based data lakes and warehouses, develops scalable data integrations, and ensures reliable, compliant delivery of clinical data products.
Responsibilities
- Own end-to-end clinical data pipelines across lake/warehouse environments (build, run, monitor, maintain, troubleshoot) to ensure stable, performant, traceable operations
- Drive operational excellence through monitoring/alerting, incident management, root-cause analysis, and corrective/preventive actions
- Build and scale cloud ETL/ELT capabilities (AWS/Azure) for efficient ingestion, transformation, orchestration, and delivery
- Automate integrations and run operations (scheduling, metadata-driven pipelines, automated quality checks) to improve reliability and timeliness
- Partner with vendors and cross-functional teams to define data transfer specifications, acceptance criteria, and integration patterns; implement integrations with robust error handling and reconciliation
- Serve as an SME for structured and unstructured data integration, driving continuous improvements through stakeholder feedback and evolving requirements
- Partner with downstream teams (Stat Programming, SDTM, Analytics, Clinical Data Programming) to deliver fit-for-purpose datasets and interfaces (format, structure, cadence)
- Ensure on-time, high-quality delivery to agreed specifications; establish and manage SLAs/OLAs as needed
- Design and deliver GxP-aligned clinical data engineering solutions with lifecycle documentation, traceability, and audit-ready evidence
- Embed data integrity controls (e.g., ALCOA+) and support validated operations via change control, incident/deviation documentation, periodic review, and inspection readiness
- Collaborate with Quality/Compliance/IT to implement appropriate access controls, logging/audit trails (as applicable), and operating controls
Skills
- BS/BA (or equivalent) plus 6+ years in data engineering, pipeline development/operations, and multi-source data integration (clinical/biopharma preferred)
- Strong SQL, data modeling, and data quality controls; working knowledge of NoSQL and integration patterns
- Proficiency in Python (preferred) or R; experience building production pipelines (testing, logging, monitoring); familiarity with SDLC practices; Jira/Confluence required
- Hands-on with CSV, JSON, XML, and API/file-based integrations
- Cloud experience (e.g., AWS such as EC2/EMR/RDS/Redshift/Apache Spark) and related platforms (e.g., Snowflake, Databricks). Pipeline and platform expertise: reusable ELT/ETL frameworks; data warehouse/data lake technologies (e.g., Snowflake, Amazon Redshift); large-scale pipeline performance and maintenance
- GitHub/GitLab version control; CI/CD exposure preferred
- Experience working in GxP-regulated environments with change control/audit readiness expectations; ability to embed data integrity controls into pipelines and operations
- Mentor junior engineers/FSPs; independent and collaborative problem-solving; ability to prioritize in a fast-paced environment and deliver to deadlines
- Strong collaboration and communication; organized, self-directed, proactive problem-solver
- Knowledge of CDISC, CDASH, and SDTM standards preferred
- Prior regulatory inspection experience preferred
- AWS/Azure and/or Python certification preferred
Benefits
- U.S. based employees may be eligible for short-term and/ or long-term incentives.
- U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time.
- New hires are eligible to accrue up to 120 hours of paid vacation.
Company Overview
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