Senior Manager, Clinical Data Enablement

Job Overview

Senior Manager, Clinical Data Enablement (remote) reporting to the Director of Clinical Data Engineering. The role is focused on operating and continuously improving end‑to‑end clinical data pipelines across cloud‑based data lake and data warehouse environments.

Operate and continuously improve end‑to‑end clinical data pipelines across cloud‑based data lake and warehouse environments. Build scalable ingestion and transformation capabilities, partner with stakeholders and vendors, and ensure reliable, compliant delivery of clinical data products.

• Own end‑to‑end clinical data pipelines (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, and operating controls.

• 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 No
  
  SQL and integration patterns.
• Proficiency in Python (preferred) or R; experience building production pipelines (testing, logging, monitoring); familiarity with SDLC practices;
  Jira/Confluence required.
• Knowledge of CDISC, CDASH, and SDTM standards preferred.
• Hands‑on with CSV, JSON, XML, and API/file‑based integrations.
• Cloud experience (AWS such as EC2/EMR/RDS/Redshift/Apache Spark) and related platforms (Snowflake, Databricks).
• Pipeline and platform expertise: reusable ELT/ETL frameworks; data warehouse/data lake technologies (Snowflake, Amazon Redshift); large‑scale pipeline performance and maintenance.
• Git Hub/Git Lab 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.
• Prior regulatory inspection experience preferred.
• AWS/Azure and/or Python certification preferred.

Location:

Massachusetts – Virtual (U.S.). Base salary range: $ – $. U.S. employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, and paid vacation. U.S. employees accrue up to 80 hours of sick time and up to 120 hours of paid vacation.

Takeda is proud of its commitment to creating a diverse workforce and provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws.

Massachusetts – Virtual. Full‑time, exempt.