Manager, DRM Systems - Business Administrator (Vault Clinical)

KPS Life
United States
14 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
7 years minimum
Working hours
Regular working hours
Job source

Tech stack

Artificial Intelligence Clinical Trial Management Systems Enterprise Document Management System Metadata Microsoft Office System Testing Systems Integration Iq/oq/pq Test Scripts Veeva VeevaVault GXP

Job description

The Manager, DRM Systems - Business Administrator is responsible for the day-to-day business operations and optimization of Veeva Vault Clinical. This role partners closely with Business Process Owners and the System Owner to support the design, configuration, maintenance, validation, and continuous improvement of the system. The position plays a key role in driving system enhancements, data migrations, integrations, and user adoption across Global Development., System Administration & Operations

  • Manage daily business functions of Vault Clinical modules, including maintenance of the system data model
  • Serve as the primary business point of contact for stakeholders across DRM, CTM, SSU, Monitoring, and GD IT
  • Manage business content including document forms, templates, metadata, controlled vocabularies, and picklists

System Enhancements & Implementation

  • Lead the evaluation, implementation, and deployment of new Veeva Vault Clinical features
  • Identify opportunities for process improvements and system enhancements through system health checks and user feedback
  • Develop and implement best practices for system use in collaboration with Veeva

Validation & Compliance

  • Maintain the validated state of the system through collaboration with technical, validation, and business teams
  • Author and execute Performance Qualification (PQ) test scripts and support validation documentation and risk assessments
  • Provide hypercare support following system upgrades and new releases

Migrations, Integrations & Automation

  • Drive the migration of records and data into Vault Clinical, including oversight of quality control with migration vendors
  • Manage integrations between Vault Clinical and other applications
  • Partner with AI vendors to document requirements, test, and implement automation solutions

Reporting, Dashboards & Metrics

  • Lead the development, maintenance, and improvement of reports, dashboards, and saved views
  • Provide metrics, trends, and compliance-related reporting to senior leadership as needed

Training & User Support

  • Deliver training and communications on new releases to a global user community of 4,000+
  • Support the development of training materials in partnership with Change Management
  • Provide end-to-end user support, including troubleshooting, triage, and analysis of support trends

Stakeholder & Vendor Management

  • Collaborate with vendors to implement new functionality and resolve system issues
  • Provide subject matter expertise on Vault Clinical during project work and vendor assessments
  • Support internal audits and regulatory inspections as required

Requirements

The ideal candidate has at least 7 years of experience supporting GxP systems in the pharmaceutical or CRO industry, along with strong knowledge of clinical trial systems such as CTMS or eTMF. Experience with Veeva Vault Clinical is strongly preferred., * Bachelor’s degree required

  • Minimum 7+ years of relevant experience supporting GxP systems in the pharmaceutical or CRO industry
  • Strong experience with clinical trial systems (CTMS or eTMF), including understanding of data models and structures

Technical & Functional Knowledge

  • Solid understanding of Computer System Validation (CSV) and system lifecycle management
  • Working knowledge of clinical trial processes and ICH/GCP guidelines
  • Experience with database management and reporting
  • Proficiency in Microsoft Office applications

Preferred Qualifications

  • Experience with Veeva Vault Clinical (highly preferred)
  • Veeva Vault Certified Administrator
  • Understanding of the TMF Reference Model

Skills & Attributes

  • Excellent written and verbal communication skills
  • Strong organizational skills with attention to detail
  • Ability to manage multiple priorities in a fast-paced environment
  • Strong interpersonal skills with the ability to work independently and collaboratively
  • Critical thinking and problem-solving capabilities

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