Senior Manager, Clinical Data Enablement
About The Position
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Manager, Clinical Data Enablement based remotely reporting to the Director, Clinical Data Engineering. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission.
Requirements
- 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.
Nice To Haves
- Knowledge of CDISC, CDASH, and SDTM standards preferred.
- Prior regulatory inspection experience preferred.
- AWS/Azure and/or Python certification preferred.
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.
Benefits
- 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
- well-being benefits
- up to 80 hours of sick time
- up to 120 hours of paid vacation
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
