Core responsibilities
System Configuration: Set up and configure Veeva Vault applications, such as CDMS (for data management) or CTMS (for trial management). This includes configuring forms, edit checks, workflows, and roles.
Clinical Processes: Apply a strong understanding of clinical trial processes, Good Clinical Practice (GCP), and regulatory requirements to configure the system to meet business needs.
User Support: Provide L2 or L3 support, troubleshoot issues, and manage change requests and enhancements for the Veeva Vault applications.
Validation & Compliance: Lead and support validation activities, including creating validation documentation and ensuring the system is compliant with regulations like GxP and 21 CFR Part 11.
Integration & Migration: Assist with integrating Veeva Vault with other clinical systems and support data migration activities from legacy systems.
Training: Provide training and support to clinical and operational users to ensure effective system adoption.
Required skills and experience
Veeva Vault Expertise: Hands-on experience with specific Veeva Vault modules like CTMS, eTMF, CDMS, Study Startup, or others.
Clinical Knowledge: Deep understanding of the clinical development lifecycle and trial processes.
Technical Skills: Experience with system configuration, data management principles, and potentially APIs, Vault APIs, or the Vault Java SDK.
Regulatory Knowledge: Familiarity with GxP, GCP, and other relevant regulatory guidelines.
Soft Skills: Excellent communication, problem-solving, analytical skills, and stakeholder management.
Certifications: Relevant Veeva Vault certifications are often a plus or sometimes mandatory.
Other Tools: Experience with tools like Jira, ServiceNow, or other ticketing and project management systems is frequently mentioned