Veeva Vault Consultant

TechDigital Corporation
Branchburg, NJ, United States
1 day ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours

Tech stack

Application Programming Interfaces (APIs) Clinical Trial Management Systems System Configuration Data Migration Enterprise Document Management System Java Development Kit Data Management VeevaVault GXP Legacy Systems 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. 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.

Requirements

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.

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