One Vector
We are seeking a Senior GxP IT Consultant to support the administration, compliance, and data enablement of regulated clinical and GxP systems. This role partners closely with Quality, Clinical Operations, and external vendors to ensure systems are compliant, well-governed, and operationally reliable across their lifecycle.
The ideal candidate is hands‑on, comfortable operating independently, and brings strong experience across CSV/CSA, GxP systems administration, clinical data platforms, and reporting/analytics.
Key Responsibilities
Provide day‑to‑day support and oversight for regulated GxP SaaS systems, including access management, periodic reviews, incident coordination, and release activities.
Support and maintain CSV/CSA documentation, including change controls, validation deliverables, and audit readiness artifacts.
Lead validation activities across the full lifecycle of GxP systems including planning, testing, deployment, and periodic review.
Partner with Quality, system owners, and vendors to ensure systems operate in compliance with 21 CFR Part 11, GxP, and data integrity expectations.
Coordinate system updates, vendor maintenance windows, and incident resolution efforts.
Support clinical data workflows and the end‑to‑end data lifecycle, including integrations, reporting, and downstream consumption.
Develop and maintain SQL‑based reports, dashboards, and data extracts to support business and operational needs.
Participate in governance forums, project meetings, and validation walkthroughs as required.
Contribute to process standardization and continuous improvement across regulated systems.
Qualifications Required:
10+ years of relevant experience supporting GxP projects
Bachelor’s or Master’s in Computer Science, Information Systems, Life Sciences, Bioinformatics, or similar.
Experience in clinical systems configuration, data engineering, clinical data platform delivery, or module implementations.
Proficiency in SQL, Python, API development/integration, ETL tools (Informatica/Talend/Fivetran), metadata management, and data lineage practices.
Strong knowledge of system validation frameworks and compliance (21 CFR Part 11, GxP, audit readiness).
Excellent ability to translate business requirements into technical configurations, collaborate with cross‑functional stakeholders, and deliver module‑based solutions.
Strong verbal and written communication skills
Able to work independently
Critical Skills:
CSV / CSA & GxP Compliance
GxP Systems Administration & Account Management
Release, Incident, and Vendor‑led System Support
SQL‑based Analytics, Data Pipelines & Reporting
Must Have:
Strong experience supporting GxP‑regulated clinical or enterprise systems
Hands‑on knowledge of CSV/CSA frameworks and audit readiness
Understanding of clinical data platforms and data lifecycle management
Proficiency with SQL and data reporting/analytics
Ability to work independently and collaborate across vendors and business stakeholders
Preferred:
Experience working directly with vendors and business system owners
Program or small‑team leadership experience
Familiarity with Elluminate® or similar clinical data platforms
Exposure to Veeva or comparable regulated SaaS platforms
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Information Technology
Industries Professional Services
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The ideal candidate is hands‑on, comfortable operating independently, and brings strong experience across CSV/CSA, GxP systems administration, clinical data platforms, and reporting/analytics.
Key Responsibilities
Provide day‑to‑day support and oversight for regulated GxP SaaS systems, including access management, periodic reviews, incident coordination, and release activities.
Support and maintain CSV/CSA documentation, including change controls, validation deliverables, and audit readiness artifacts.
Lead validation activities across the full lifecycle of GxP systems including planning, testing, deployment, and periodic review.
Partner with Quality, system owners, and vendors to ensure systems operate in compliance with 21 CFR Part 11, GxP, and data integrity expectations.
Coordinate system updates, vendor maintenance windows, and incident resolution efforts.
Support clinical data workflows and the end‑to‑end data lifecycle, including integrations, reporting, and downstream consumption.
Develop and maintain SQL‑based reports, dashboards, and data extracts to support business and operational needs.
Participate in governance forums, project meetings, and validation walkthroughs as required.
Contribute to process standardization and continuous improvement across regulated systems.
Qualifications Required:
10+ years of relevant experience supporting GxP projects
Bachelor’s or Master’s in Computer Science, Information Systems, Life Sciences, Bioinformatics, or similar.
Experience in clinical systems configuration, data engineering, clinical data platform delivery, or module implementations.
Proficiency in SQL, Python, API development/integration, ETL tools (Informatica/Talend/Fivetran), metadata management, and data lineage practices.
Strong knowledge of system validation frameworks and compliance (21 CFR Part 11, GxP, audit readiness).
Excellent ability to translate business requirements into technical configurations, collaborate with cross‑functional stakeholders, and deliver module‑based solutions.
Strong verbal and written communication skills
Able to work independently
Critical Skills:
CSV / CSA & GxP Compliance
GxP Systems Administration & Account Management
Release, Incident, and Vendor‑led System Support
SQL‑based Analytics, Data Pipelines & Reporting
Must Have:
Strong experience supporting GxP‑regulated clinical or enterprise systems
Hands‑on knowledge of CSV/CSA frameworks and audit readiness
Understanding of clinical data platforms and data lifecycle management
Proficiency with SQL and data reporting/analytics
Ability to work independently and collaborate across vendors and business stakeholders
Preferred:
Experience working directly with vendors and business system owners
Program or small‑team leadership experience
Familiarity with Elluminate® or similar clinical data platforms
Exposure to Veeva or comparable regulated SaaS platforms
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Information Technology
Industries Professional Services
#J-18808-Ljbffr