Technical Lead
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Job Location:
Somerset County, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Technical Lead
Location: Branchburg NJ
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
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
Key Skills
- Administrative Skills
- Facilities Management
- Biotechnology
- Creative Production
- Design And Estimation
- Architecture
