Clinical Data Enablement Senior Manager

Greetings !

Job Summary

The Clinical Data Enablement Senior Manager (FSP) is responsible for designing, implementing, operating, and continuously improving end-to-end clinical data pipelines across cloud-based data lake and data warehouse environments. This role ensures the reliable, secure, and compliant delivery of clinical data products by developing scalable data engineering solutions, automating data integration processes, and collaborating with internal stakeholders, external vendors, and downstream consumers. The position plays a key role in maintaining operational excellence while adhering to GxP and regulatory requirements.

Key Responsibilities

• Design, develop, maintain, monitor, and optimize end-to-end clinical data pipelines across cloud-based data lake and data warehouse platforms.
• Build scalable ETL/ELT frameworks for clinical data ingestion, transformation, orchestration, and delivery using AWS or Azure cloud technologies.
• Automate data integration processes, workflow scheduling, metadata-driven pipelines, and data quality validations to improve operational efficiency.
• Monitor production pipelines, perform incident management, conduct root cause analysis, and implement corrective and preventive actions.
• Collaborate with internal business teams, external vendors, and technology partners to define data transfer specifications, integration standards, and acceptance criteria.
• Support structured and unstructured clinical data integration while ensuring data accuracy, consistency, and traceability.
• Partner with Statistical Programming, Clinical Data Programming, SDTM, and Analytics teams to deliver high-quality, fit-for-purpose datasets.
• Develop and maintain operational dashboards and KPI reports to monitor pipeline health, data quality, processing success rates, and service performance.
• Ensure timely delivery of clinical data products while managing SLAs and operational performance metrics.
• Design GxP-compliant data engineering solutions with complete lifecycle documentation, audit trails, and validation evidence.
• Implement ALCOA+ data integrity principles, change control processes, incident documentation, and inspection readiness activities.
• Collaborate with Quality, Compliance, IT, and business stakeholders to implement security controls, access management, logging, and audit capabilities.
• Mentor junior engineers and promote engineering best practices, continuous improvement, and knowledge sharing across teams.

Required Qualifications

• Bachelor''s degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related discipline.
• 7+ years of experience in data engineering, clinical data integration, ETL/ELT development, or cloud data platform operations, preferably within the pharmaceutical, biotechnology, or CRO industry.
• Strong programming skills in Python (preferred), SQL, and working knowledge of R.
• Experience with AWS or Azure cloud services, including technologies such as EC2, EMR, RDS, Redshift, Apache Spark, Snowflake, and Databricks.
• Hands-on experience designing and supporting data lake and data warehouse solutions.
• Knowledge of REST APIs, JSON, XML, CSV, NoSQL databases, and file-based data integrations.
• Experience with GitHub/GitLab, CI/CD pipelines, SDLC methodologies, Jira, and Confluence.
• Familiarity with Power BI, Tableau, or QlikView for operational reporting and dashboard development.
• Knowledge of clinical data standards including CDISC, CDASH, and SDTM.
• Experience working within GxP-regulated environments, including data integrity, change control, validation, and audit readiness.