What are the responsibilities and job description for the Lead Veeva Vault Consultant (Clinical) position at SIMARN Solutions?
About the Role
We are looking for an experienced Lead Veeva Vault Consultant (Clinical) to join a high-impact project in the life sciences domain. This role requires deep functional and technical expertise in the Veeva Vault Clinical suite along with strong consulting, stakeholder management, and delivery capabilities.You will play a key role in designing, configuring, and supporting Veeva Vault applications to meet business and regulatory requirements, while ensuring high-quality and timely delivery.
Key Responsibilities
Solution Delivery & Configuration
- Configure and implement Veeva Vault Clinical applications such as CTMS, eTMF, CDMS, and Study Startup
- Design forms, workflows, roles, and edit checks aligned with business requirements and quality standards
Clinical & Regulatory Alignment
- Apply expertise in clinical trial processes and GCP
- Ensure system configurations meet regulatory standards (GxP, 21 CFR Part 11)
Analysis & Problem Solving
- Perform qualitative and quantitative analysis to identify issues and optimize processes
- Deliver client-specific, scalable solutions
Stakeholder Collaboration
- Partner with cross-functional teams (Clinical, IT, QA, Regulatory)
- Communicate effectively across stakeholders throughout the project lifecycle
Support & Enhancements
- Provide L2/L3 support, troubleshoot issues, and manage change requests
- Handle system enhancements and performance improvements
Validation & Compliance
- Lead validation activities (IQ/OQ/PQ documentation, test scripts)
- Ensure ongoing compliance with regulatory frameworks
Integration & Data Migration
- Support integration of Veeva Vault with other clinical systems
- Assist with data migration from legacy systems
Training & Adoption
- Deliver training and user support for clinical and operational teams
- Drive adoption and effective usage of the platform
Required Skills
- Strong hands-on experience with Veeva Vault Clinical modules (CTMS, eTMF, CDMS, etc.)
- Deep understanding of clinical trial lifecycle and processes
- Experience in Vault configuration, workflows, and system setup
- Knowledge of Vault APIs / Vault SDK (preferred)
- Familiarity with GxP, GCP, and 21 CFR Part 11 compliance
- Strong analytical, problem-solving, and stakeholder management skills
- Excellent communication and presentation abilities
Preferred Qualifications
- Veeva Vault certifications (highly valued)
- Experience working in life sciences or pharmaceutical consulting environments
- Familiarity with tools like Jira, ServiceNow, or similar ticketing systems