Senior Manager, Clinical Data Enablement

Job Description

Senior Manager, Clinical Data Enablement, reporting to the Director of Clinical Data Engineering s role operates and continuously improves end‑to‑end clinical data pipelines across cloud‑based data lake and data warehouse environments. The Senior Manager builds scalable ingestion and transformation capabilities, partners closely with internal stakeholders and external vendors, and ensures reliable, compliant delivery of clinical data products to downstream consumers.

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

• 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.

• 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 (e.g., AWS such as EC2/EMR/RDS/Redshift/Apache Spark) and related platforms (Snowflake, Databricks). Reusable ELT/ETL frameworks; data warehouse/data lake technologies; 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: $ – $ The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant…