Manager, Veeva Vault Administration (Contract)

Vault Configuration & Solution Delivery (40-60%)

• Collaborates with cross-functional stakeholders to gather, analyze, and translate business needs into actionable requirements & specifications for Vault Clinical applications.
• Configures, validates, and implements Vault Clinical solutions across all applications, including workflows, lifecycles and metadata.
• Coordinates planning & deployment of vendor platform updates, including evaluation of new features & releases, impact analysis, readiness assessments, and production roll-out.
• Identifies and recommends innovative Vault Clinical enhancements aligned with Alimentiv’s strategic direction & roadmap for the platform.
• Collaborates with business and technical stakeholders to execute data migrations and system integrations (e.g., EDC) connected to Veeva Vault.
• Ensures alignment and consistency of configurations across Vault Clinical applications, coordinating with delivery & support staff to maintain a coherent architecture.

Vault Maintenance, Security & Compliance (30-50%)

• Maintains configuration of Vault Clinical applications (eTMF, CTMS, Study Training, Study Startup, Site Connect) and underlying Vault Platform data architecture (Global Directory).
• Manages system change requests, applying change controls in accordance with internal policies & SOPs and external regulations.
• Manages user accounts & permissions, applying role-based access principles and conducting user access reviews.
• Liaises with vendor support & professional services for issue resolution and escalation when required.
• Oversees data governance of Vault Platform, monitoring data integrity and quality.
• Conducts system risk assessments and develops & applies mitigations to ensure security, integrity and availability of the platform in accordance with GxP regulations (21 CFR Part 11, EMA) and ISO 27001 principles.
• Maintain system documentation, including validation deliverables, SOPs and work instructions, to ensure regulatory compliance and audit readiness.

Vault User Enablement, Support & Training (10-25%)

• Oversee user training and development & maintenance of comprehensive training resources to drive user adoption and support effective system use.
• Provide technical support and guidance to internal and external Vault Clinical users, ensuring timely resolution of system issues and user inquiries.
• Serves as a trusted partner to non-technical users, ensuring clear communication and practical guidance to support adoption and effective use of the platform.
• Develop and maintain reports and dashboards for internal and external users leveraging Vault Clinical data to support operational visibility and decision-making.

Team Management & Engagement (10-15%)

• Formally supervise and oversee the work of internal Veeva solution delivery & support staff.
• Assign and prioritize workloads to ensure timelines and quality expectations are met.
• Support recruitment activities, including onboarding and training new team members.
• Set, track, and evaluate performance objectives to align with departmental strategies.
• Conduct performance reviews and support team competency development.
• Provide conflict resolution support and maintain positive team morale.
• Monitor resourcing, capacity, and availability of staff, escalating concerns to Sr leadership as required

Qualifications

• 7 – 9 years of related experience
• (Honors) Bachelor’s degree
• English fluency (written and verbal)
• Veeva Vault Platform Administrator or Veeva Clinical Operations Administrator certification is required, with demonstrated strong knowledge of Veeva configuration tools.
• Prior knowledge & experience with configuration & administration of Veeva Vault Clinical applications including eTMF, CTMS, Study Startup, Study Training, and Site Connect
• Knowledge of database management and data governance concepts & principles for oversight of underlying Veeva Vault data architecture (Global Directory)
• Experience with Veeva Vault data migrations.
• Experience with integrating Veeva Vault with other clinical applications (e.g., EDC).
• Knowledge of full computer system validation lifecycle and deliverables (requirements, specifications, IQ, OQ, PQ/UAT), with Veeva-specific experience preferred.
• Knowledge of IT security protocols and regulatory compliance requirements (e.g., FDA 21 CFR Part 11,) including implementing secure access controls and ensuring data integrity and audit trails in clinical systems
• Understanding of global regulations affecting clinical trials, including ICH-GxP, FDA guidelines, and data privacy laws in various regions (e.g., GDPR).
• Proven ability to self-direct work, manage priorities independently, and collaborate with non-technical stakeholders to deliver functional solutions.
• Technical Documentation: Knowledge of creating and maintaining technical documentation, such as system manuals, standard operating procedures (SOPs), and user guides for clinical systems.
• Problem-Solving: The ability to quickly diagnose system issues, troubleshoot effectively, and implement solutions independently.
• Adaptability: Ability to adapt to new technologies and evolving regulatory requirements in the clinical space, and willingness to continuously learn and improve.
• Communication Skills: Strong written and verbal communication skills to work effectively with cross-functional teams, present technical information to non-technical stakeholders, and provide training and support to users.
• Attention to Detail: The ability to pay close attention to regulatory requirements and data accuracy, ensuring compliance and data integrity in clinical systems.
• Project Management and Organization: Strong organizational and time-management abilities to handle multiple projects simultaneously, ensuring timely implementation of system changes or upgrades.