09 Aug
|
PrimeForce Solutions
|
India
09 Aug
PrimeForce Solutions
India
Job Title
Veeva Vault Administrator – Clinical
Experience
3–8 Years
Location
Remote
Job Summary
We are seeking an experienced Veeva Vault Administrator – Clinical to manage, configure, and support the Veeva Vault Clinical platform, ensuring system reliability, regulatory compliance, and efficient business operations. The ideal candidate will have hands-on experience administering Veeva Vault Clinical applications, supporting end users, implementing configuration changes, and participating in Computer System Validation (CSV) activities.
Experience with change management, release management, and platform administration is highly preferred.
Key Responsibilities
Veeva Vault Platform Administration
Administer and maintain Veeva Vault environments (Production, Sandbox, Validation, and Training).
Configure and maintain users, security profiles, roles, permissions, and access controls.
Create and manage domains, lifecycles, workflows, object configurations, page layouts, and field-level security.
Configure document types, document lifecycles, object lifecycles, workflows, and notifications.
Support application configuration through Vault configuration tools while following best practices.
Perform environment setup and refresh activities for testing and validation.
Monitor scheduled jobs, system logs, integrations, and platform health.
Coordinate Vault release readiness activities and evaluate the impact of quarterly Veeva releases.
Support deployment of configuration changes across environments.
Maintain platform documentation, configuration guides, and administration procedures.
Clinical Vault Administration
Administer Veeva Vault Clinical applications including CTMS, eTMF, Study Startup, Payments, Site Connect, and related Clinical modules.
Configure studies, study teams, study roles, countries, sites, organizations, and clinical reference data.
Support study setup activities and ensure adherence to organizational standards.
Manage user onboarding, role assignments, study access, and permission updates.
Troubleshoot application issues and provide Level 2/Level 3 support to business users.
Monitor clinical integrations and identify data synchronization issues.
Support reporting requirements by creating or maintaining standard and custom reports.
Assist study teams in resolving data discrepancies and system-related issues.
Coordinate with business stakeholders, vendors, and Veeva Managed Services for issue resolution.
Change Management & Release Support
Prepare and review Change Control documentation.
Perform impact assessments for configuration changes and enhancements.
Support deployment activities following SDLC and change management processes.
Participate in release planning, implementation, and post-deployment verification.
Maintain deployment documentation and rollback plans where applicable.
Ensure all changes comply with GxP and regulatory requirements.
Computer System Validation (CSV)
Participate in validation activities for new implementations, enhancements, and platform releases.
Prepare and execute User Acceptance Testing (UAT) scripts.
Develop Validation Plans, Test Scripts, Traceability Matrix, and Validation Summary Reports (VSR).
Execute IQ/OQ/PQ activities where applicable.
Document test evidence and manage validation artifacts.
Coordinate defect tracking, retesting, and validation closure activities.
Ensure compliance with GAMP 5, FDA 21 CFR Part 11, Annex 11, and internal validation procedures.
Documentation & Compliance
Maintain SOPs, Work Instructions, Configuration Documents, and Administration Guides.
Support periodic system reviews and audit readiness activities.
Assist during internal and external audits by providing required documentation and evidence.
Ensure compliance with company quality standards and regulatory guidelines.
Maintain accurate system documentation and configuration inventories.
Required Skills
Strong experience administering Veeva Vault Clinical applications.
Hands-on experience with Vault configuration and administration.
Knowledge of Clinical Trial Management processes and clinical operations.
Experience with user management, security, workflows, lifecycles, and object configuration.
Positive understanding of SDLC, Change Control, and Release Management.
Experience with Computer System Validation (CSV) activities.
Ability to write and execute UAT scripts and document validation evidence.
Strong analytical and troubleshooting skills.
Excellent communication and stakeholder management skills.
Preferred Skills
Experience with one or more Veeva Vault Clinical applications:
Clinical Operations (CTMS)
eTMF
Study Startup
Site Connect
Experience supporting integrations with EDC, eTMF, RIM, Safety, or external systems.
Knowledge of REST APIs, Vault Loader, Vault API, and data migration tools.
Experience with SQL, reporting tools, Power BI, or data analytics is an added advantage.
Familiarity with Jira, Azure DevOps, ServiceNow, or similar ticketing tools.
Understanding of GxP regulations and pharmaceutical clinical development processes.
Qualifications
Bachelor's degree in Computer Science, Information Technology, Life Sciences, Pharmacy, or a related field.
Veeva Vault Certification is preferred and will be considered an added advantage.
Preferred Experience
3–8 years of experience in Veeva Vault administration.
Experience supporting global clinical studies and cross-functional business teams.
Experience working in regulated pharmaceutical, biotechnology, or CRO environments.
Exposure to Veeva quarterly release management and validation processes.
📌 Veeva Vault Administrator - Clinical (Remote) (India)
🏢 PrimeForce Solutions
📍 India