Technical Lead

Technical Lead 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. E-Solutions