eTMF Solutions Specialist - Business & Systems Liaison

Excelya; Boston (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

Excelya is seeking a clinical systems professional to join our eTMF team in the United States. You will translate business needs into functional specifications, support testing and validation, and work closely with Clinical Operations stakeholders and project managers.

This role focuses on Veeva Vault eTMF administration, system enhancements, CSV contributions, and cross-functional collaboration across global teams. Fluency in English is required.

Qualifications

• Hands-on with Veeva Vault eTMF and solid understanding of eTMF processes.
• Experience in Clinical Operations within a clinical research setting.
• Knowledge of computerized systems in GxP-regulated environments.
• Strong understanding of CSV principles and activities.
• Experience managing system changes, change controls and lifecycle activities.
• Ability to translate business needs into functional specs and user stories.
• Experience preparing, executing and coordinating testing activities including UAT.

Responsibilities

• Support administration, maintenance, and continuous improvement of the Veeva Vault eTMF platform.
• Serve as functional point of contact for eTMF and Clinical Operations stakeholders.
• Gather, analyze, and translate business requirements into functional specs and user stories.
• Support system enhancements, releases, and new functionalities.
• Prepare and execute testing activities including UAT and manage issue resolution.
• Contribute to CSV, change control, and GxP compliance activities.
• Provide user support and training across cross-functional teams.

Skills

Veeva Vault eTMF

eTMF processes

CSV principles

GxP environment

UAT coordination

stakeholder management

English proficiency

Job description

Excelya is seeking a clinical systems professional to join our eTMF team in the United States. You will translate business needs into functional specifications, support testing and validation, and work closely with Clinical Operations stakeholders and project managers.

This role focuses on Veeva Vault eTMF administration, system enhancements, CSV contributions, and cross-functional collaboration across global teams. Fluency in English is required.