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Job summary
A clinical technology firm in New Jersey is seeking a professional proficient in Veeva Vault applications to configure systems for clinical trials. The role requires expertise in Veeva Vault modules, a solid understanding of clinical processes, and technical skills for system configuration. This position includes training end users, providing support, and ensuring compliance with regulatory requirements. Relevant certifications and knowledge of regulatory guidelines are highly valued. Experience with tools like Jira is a plus.
Qualifications
Hands-on experience with Veeva Vault modules like CTMS or CDMS.
Deep understanding of the clinical development lifecycle.
Experience with system configuration and data management principles.
Familiarity with GxP and GCP regulations.
Excellent communication and problem-solving skills.
Relevant Veeva Vault certifications.
Experience with ticketing and project management systems.
Responsibilities
Configure Veeva Vault applications and manage workflows.
Apply knowledge of clinical trial processes to system configuration.
Provide L2/L3 support and manage change requests.
Lead validation activities ensuring regulatory compliance.
Assist with system integration and data migration.
Train users on effective system adoption.
Skills
Veeva Vault Expertise
Clinical Knowledge
Technical Skills
Regulatory Knowledge
Soft Skills
Certifications
Other Tools
Tools
Jira
ServiceNow
Job description
Mandatory Skills
Veeva Vault Clinical
JD:
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.