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Alimentiv · 18 hours ago

Manager, Veeva Vault Administration

Ontario, CA

Full-time

Onsite

Mid, Senior Level

$89K/yr - $148K/yr

7+ years exp

Alimentiv is seeking a Manager for Veeva Vault Administration, responsible for the administration and operational delivery of the Veeva Vault platform. The role focuses on translating strategic technology priorities into practical solutions and ensuring effective user adoption through training and support.

BiotechnologyClinical TrialsConsultingHealth CarePharmaceuticalPrecision Medicine

Culture & Values

Responsibilities

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

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

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

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

Qualification

Veeva Vault AdministrationVeeva Vault ConfigurationData GovernanceRegulatory ComplianceDatabase ManagementVeeva Vault CertificationSystem IntegrationTechnical DocumentationProblem-SolvingAdaptabilityCommunication SkillsAttention to DetailProject Management

Required

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

Company

Alimentiv

Industry-leading specialty GI contract research organization (CRO) transforming clinical trial outcomes and accelerating the development of life-changing therapies.

Founded in 1986

London, Ontario, CAN

501-1000 employees