Senior Manager, Clinical Data Enablement
Core
Operating and continuously improving end-to-end clinical data pipelines across cloud-based data lake and data warehouse environments to ensure reliable, compliant delivery of clinical data products.
Role type
Senior Manager, Clinical Data Engineering (GxP)
Builds
Scalable ingestion and transformation capabilities for clinical data products
Domain
Biopharmaceutical R&D / Clinical Data Engineering
Deliverable
production ML models | product features | infrastructure
Required skills
Cloud data engineering (AWS/Azure), SQL, data modeling, data quality controls, Python or R, SDLC practices, GxP compliance, change control, incident management, vendor partnership, SLA management
Preferred skills
CDISC/CDASH/SDTM standards, NoSQL, CI/CD, regulatory inspection experience, AWS/Azure or Python certification
Technologies
AWS (EC2/EMR/RDS/Redshift/Apache Spark), Snowflake, Databricks, Jira, Confluence, GitHub/GitLab, CSV, JSON, XML
Responsibilities
Own end-to-end clinical data pipelines (build, run, monitor, maintain, troubleshoot); Drive operational excellence through monitoring/alerting and root-cause analysis; Build and scale cloud ETL/ELT capabilities; Automate integrations and run operations; Partner with vendors and cross-functional teams to define data transfer specifications; Serve as SME for structured and unstructured data integration; Partner with downstream teams to deliver fit-for-purpose datasets; Ensure on-time, high-quality delivery and manage SLAs/OLAs; Design and deliver GxP-aligned clinical data engineering solutions with lifecycle documentation; Embed data integrity controls (ALCOA+) and support validated operations; Collaborate with Quality/Compliance/IT to implement access controls and audit trails
Seniority
Senior Manager, hands-on IC with mentorship responsibilities