Kenneth Steinberg

- Managed global implementation of Veeva Vault SafetyDocs (PSMF, PVA, PV Reg Intel) to replace manual processes and remediate internal audit findings, and to ensure compliance-readiness for upcoming EU product launches. - Led post-acquisition migration of regulatory documents from legacy Veeva Vault to Submissions Vault, ensuring compliance and preserving data integrity. - Piloted Gen AI-based literature review solution, streamlining research workflows, reducing bias, and improving review quality.

Senior IT Program and Project Manager with 20+ years' experience delivering complex, global initiatives in regulated Life Sciences environments. Based in the United States; dual US / Irish citizen.

- For an eTMF implementation, led business process improvement workstreams; upgrade of incumbent PhlexEview system; vendor selection; implementation of Veeva Vault eTMF; CSV and SDLC activities; migration of studies; organizational change management; and multi-vendor, schedule and budget management. - Led selection of a Clinical Data Platform, CTMS and EDC, with a focus on data integration, reporting, and analytics to support query management, data reconciliation, and trial oversight.

Operational PM, managing changes to production systems, primarily Veeva Vault, focused primarily in the Clinical, Medical Affairs, Quality, and Regulatory domains. Establish “templatized” governance at the project level, and broader, overall governance at the operational level.

insight and control. Signature project involved implementation of a human sample management platform to provide oversight of human sample lineage and compliance with informed consent, and as the initial use case for a broader Research Data Lake initiative.

Led eight, simultaneous platform migrations as part of acquisition of two new sites. Provided compliance and Quality oversight; managed performance to milestones for multiple cross-functional, cross-site teams; assessed adequacy of change plans, data verification / validation plans; and maintained timely and open communication with stakeholders.

Manage GxP systems SDLC, both for changes to existing production systems as well as implementation projects, including associated change management, business process improvement and governance. Plan and manage project budgets, schedules and cross-functional, matrix project teams.

Directed GxP systems planning, project management, development, validation, and production support. Jointly developed IT quality management, security, and project management methodologies. Led change management process for both GxP and non-GxP IT changes. Managed development of all IT-related SOPs.

Managed application development and implementation projects for Eisai network companies, both validated and non-validated systems. Led cross functional, globally matrixed project teams through the full SDLC. Managed all aspects of project, system and validation lifecycles.

Implemented $2M custom Chemistry, Manufacturing and Controls (CMC) intranet application to centralize and standardize CMC data for Pfizer's Global Manufacturing Compliance group.

Secondary school education