Manager, Veeva Vault Administration (Contract)

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.