Data Governance & Analytics Lead; GA

Overview

Role:
Data Governance & Analytics Lead (GA4)

Location:
Raritan NJ (Onsite)

Duration:
Long Term

1 GxP Compliant Analytics Architecture Validation

• Design and implement validated GA4 architectures aligned with GXP 21 CFR Part 11 and internal SDLCCSV frameworks Develop and maintain validation documentation including
• User Requirements Specification URS
• Functional Specification FS
• Design Specification DS
• Operational Qualification OQ
• Performance Qualification PQ
• Ensure analytics implementations meet ALCOA principles Attributable Legible Contemporaneous Original Accurate
• Partner with Quality Assurance QA and Computer System Validation CSV teams to support system qualification and audit readiness

2 Data Governance Security Compliance

• Establish enterprise wide data governance frameworks for digital analytics data across patient HCP and consumer platforms Implement controls to ensure compliance with HIPAA Protected Health Information handling
• GDPR CCPA data privacy and consent
• Internal JJ security and risk management standards
• Configure role based access control RBAC audit trails and logging mechanisms for analytics platforms Ensure restricted access to sensitive logs and enforce segregation of duties SoD

3 Tag Management Controlled Tracking Framework

• Lead implementation using Google Tag Manager under controlled deployment pipelines Dev QA Prod Develop standardized validated event tracking frameworks for
• Clinical and digital health applications
• Marketing and HCP engagement platforms
• Implement change control processes for all tracking updates ensuring traceability and approval workflows Enforce version control rollback mechanisms and audit logging for all tagging activities

4 Data Integration Regulated Data Engineering

• Integrate analytics data with enterprise platforms such as
• Clinical systems
• Data lakes warehouses like Google Big Query.
• Design pipelines that ensure
• Data lineage and traceability Validation of transformations
• Controlled ingestion of regulated data
• Collaborate with data engineering teams to enable validated ETL ELT processes

5 Reporting Auditability Inspection Readiness

• Develop compliant dashboards using Looker Studio and enterprise BI tools
• Ensure all reports are
• Traceable to source data
• Reproducible and validated
• Aligned with approved business logic
• Support regulatory inspections and internal audits by providing
• Access logs and validation artifacts
• Implement consent management integrations ensuring user tracking aligns with patient privacy requirements
• Design data minimization strategies to avoid collection of unnecessary sensitive data
• Enable anonymization and pseudonymization techniques within GA4
• Ensure strict separation between PHI and nonPHI datasets
• Build automated monitoring frameworks for
• Compliance violations
• Implement proactive alerting and incident response mechanisms
• Develop scripts and tools for continuous compliance checks and audit readiness