Veeva Business Analyst

Job Description

The Clinical Business Administrator supports Study Teams, functional representatives and external partners in the effective use and administration of Veeva Clinical Vault.

The role contributes to high-quality clinical documentation and records management, inspection readiness and efficient processes throughout the study lifecycle. It provides technical and process guidance to clinical end users and works closely with business functions, Global Information and Communication Technologies (GICT) and service providers to ensure that Clinical Vault configuration, reference data, user access and routine administrative activities remain aligned with Chiesi processes, applicable procedures and regulatory requirements.

All activities are performed in accordance with Chiesi SOPs, Work Instructions, policies and practices, Good Clinical Practice, applicable regulatory requirements, approved budgets, and defined quality and timeline expectations.

Key Activities and Responsibilities

1. User Access Management

• Coordinate with GICT the activation, modification and deactivation of internal and external Clinical Vault users.
• Periodically review user access rights to confirm continued alignment with assigned study roles, responsibilities and applicable access-control requirements.
• Support the timely resolution of access-related requests and issues.
• Support the creation and management of temporary system access for auditors and inspectors during audits and regulatory inspections.

User accounts, groups, security profiles and permission sets are core areas of Vault administration and determine access to administrative functions and content.

2. Clinical Vault Business Administration

• Execute routine Veeva Clinical Vault administrative activities in accordance with approved SOPs and Work Instructions, including study creation.
• Create, maintain and update business-administered records and reference data.
• Ensure that reference data are entered accurately, consistently and in accordance with established Chiesi standards.
• Manage applicable business process values, metadata, controlled vocabularies and picklists.
• Monitor data quality and support the correction of inaccurate or incomplete system records.

Veeva Business Administration includes the management of object records, picklists and templates, while broader Vault administration covers users, configuration, logs, deployment and connections.

3. System Configuration and Maintenance Support

• Support GICT with the assessment and configuration of Clinical Vault functionalities.
• Help ensure that system configuration remains aligned with Chiesi business processes, internal standards and applicable global regulatory requirements.
• Translate business requirements and operational needs into clear functional inputs and technical specifications.
• Participate in the assessment of proposed system changes, enhancements and configuration updates.
• Support testing, validation and controlled implementation of approved changes.
• Contribute to the identification of system and process improvements based on operational experience and user feedback.

4. Vault Connections and Integrations

• Support the configuration and maintenance of connections between different Chiesi Vaults.
• Assess potential impacts of connection changes on Veeva Clinical Vault, its data and associated business processes.
• Collaborate with GICT and relevant business stakeholders in investigating and resolving connection or integration issues.
• Support impact assessments and testing when connections or integrated processes are modified.

Veeva Vault administration includes the management of Vault-to-Vault and external connections, as well as configuration migration and deployment activities.

5. Study and Data Migration Support

• Support study migrations when required, including in the context of acquisitions or portfolio transfers.
• Assist internal teams and service providers with data and document mapping activities.
• Ensure alignment between business requirements, source information and technical migration specifications.
• Contribute to migration planning, testing, validation and quality-control activities.
• Support post-migration review and resolution of identified discrepancies.

6. End-User Support and Guidance

• Provide technical and process guidance to clinical end users to enable the effective and compliant use of electronic clinical systems.
• Respond to user queries and support the resolution of system, data and process-related issues.
• Collaborate with GICT and other support functions to investigate issues requiring technical intervention.
• Communicate system processes, changes and requirements in clear, business-oriented language.
• Contribute to user guidance, quick-reference materials, training sessions and knowledge-sharing activities, as appropriate.

7. Audit and Inspection Support

• Provide Clinical Vault system and process support during internal audits, partner audits and regulatory inspections.
• Coordinate the activation, modification and removal of auditor and inspector access.
• Support the retrieval and presentation of relevant system information and records.
• Assist with audit-trail reviews and the investigation of system-related questions or observations.
• Ensure that access and support activities are performed in accordance with applicable procedures and security requirements.

8. Quality, Compliance and Inspection Readiness

• Support high-quality clinical documentation and records management throughout the study lifecycle.
• Contribute to ongoing inspection readiness by maintaining accurate, complete, consistent and traceable system records.
• Perform activities in compliance with GCP, Chiesi SOPs, Work Instructions, policies and practices, approved budgets and applicable regulatory requirements.
• Operate in accordance with defined quality standards, timelines and service expectations.
• Support system validation and controlled system lifecycle activities, where applicable.

Candidate Requirements

Education and Experience

• Bachelor's degree in Life Sciences, Information Technology, Clinical Research, Business Administration or a related discipline, or equivalent relevant professional experience.
• Relevant experience in clinical operations, clinical systems, eTMF, CTMS, document management or business system administration within a pharmaceutical, biotechnology or CRO environment.
• Hands-on experience with Veeva Vault Clinical applications, preferably Veeva eTMF and/or Veeva CTMS.
• Previous experience in a GxP-regulated environment.
• Experience supporting business users, system administration activities, access management, reference data or study setup.
• Experience with system validation, data migration, controlled system changes or release-impact assessments is desirable.
• Veeva Vault Administrator certification is an advantage but should not necessarily be considered mandatory. Current industry vacancies commonly request Veeva Clinical experience and treat Veeva Vault certification as a preferred qualification.

Technical and Regulatory Knowledge

• Understanding of clinical trial processes and the clinical study lifecycle.
• Working knowledge of ICH-GCP, GxP principles and applicable clinical documentation requirements.
• Knowledge of electronic Trial Master File and Clinical Trial Management System processes.
• Understanding of role-based access, permission management, controlled vocabularies, metadata, reference data and audit trails.
• Awareness of computer system validation principles and regulated system lifecycle management.
• Familiarity with the TMF Reference Model is desirable.
• Basic understanding of system integrations, Vault-to-Vault connections and data migration principles is an advantage.
• Proficiency in Microsoft 365 applications, particularly Excel, Word, PowerPoint and Teams.

Core Competencies

• Strong attention to detail and commitment to data quality.
• Ability to interpret procedures and apply them consistently in day-to-day system administration.
• Strong analytical, troubleshooting and problem-solving capabilities.
• Ability to translate business needs into clear functional requirements.
• Effective written and verbal communication skills in English.
• Ability to explain technical or system-related topics clearly to non-technical clinical users.
• Strong organizational skills and ability to manage multiple requests and priorities.
• Ability to work independently while collaborating effectively with Study Teams, functional representatives, GICT, external partners and service providers.
• Proactive, service-oriented and continuous-improvement mindset.
• Sound judgment when handling confidential information, system access and inspection-related requests.
• Ability to work effectively in a cross-functional and regulated environment.
• Work in US Eastern Timezone

Preferred Experience

• Experience with Veeva Clinical Vault study creation and maintenance.
• Experience administering user accounts, roles, groups and permissions.
• Experience managing reference data, object records, metadata, picklists or controlled vocabularies.
• Participation in Veeva release assessments, change controls, testing or validation activities.
• Experience supporting audits and regulatory inspections.
• Experience with study migrations, acquisitions or transfers between clinical systems.
• Experience working with external CROs, technology providers or implementation partners.
• Experience developing reports, dashboards, training materials or user guidance.
• Knowledge of data integrity principles and audit-trail review.