Manager, Veeva Vault Administration (Contract)

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.