Opportunity DetailsOn Assignment
Manager, DRM Systems - Business Administrator (Vault Clinical)Remote, USA
Manager, DRM Systems - Business Administrator (Vault Clinical)
Position Summary
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.
Key Responsibilities
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
Education & Experience
- 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
