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.

Requirements

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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

Veeva VaulteTMFCTMSStudy StartupStudy TrainingSite Connectdata governancedata migrationssystem integrationcomputer system validation

Soft skills

communication skillsproblem-solvingadaptabilityattention to detailproject managementorganizational skillscollaborationself-directionconflict resolutionteam supervision

Certifications

Veeva Vault Platform AdministratorVeeva Clinical Operations Administrator