eTMF Specialist

Excelya; Boston (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

Excelya is seeking an experienced eTMF consultant to join our US-based team. You will work closely with the new eTMF Director in the United States and Clinical Operations stakeholders to translate business needs into system requirements and validation activity.

You'll support Veeva Vault eTMF administration, testing, CSV and change control, and provide user training across global teams, ensuring GxP compliance and a seamless trial lifecycle.

Qualifications

• Hands-on experience with Veeva Vault eTMF and strong understanding of eTMF processes.
• Solid knowledge of Clinical Operations within a clinical research environment.
• Experience working with computerized systems in GxP-regulated settings.
• Good understanding of Computerized System Validation (CSV) principles and activities.
• Experience managing system changes, change controls, and system lifecycle activities.
• Ability to gather business requirements and translate them into functional specifications and User Stories.
• Experience preparing, executing, and coordinating testing activities, including UAT.
• Strong communication and stakeholder management skills, with experience working in global cross-functional teams.
• Fluent in English.

Responsibilities

• Support the administration, maintenance, and continuous improvement of the Veeva Vault eTMF platform.
• Serve as a functional point of contact for eTMF and Clinical Operations stakeholders.
• Gather, analyze, and translate business requirements into functional specifications and user stories.
• Support system enhancements, releases, and the implementation of 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 while collaborating with Clinical Operations, Quality, IT, and global teams.

Skills

Veeva Vault eTMF

eTMF processes

Clinical Operations

GxP compliance

CSV principles

UAT testing

Change control

User stories

Stakeholder mgmt

English fluent

Job description

JoinExcelya,whereAudacity,Care,andEnergydefinewhoweareandhowwework.Webelieveincreatingboldsolutionsandfosteringaninclusiveenvironmentwherecollaborationandindividualgrowthgohandinhand.

In this role, you will join an existing eTMF team and work closely with the new eTMF Director based in the United States, as well as with Clinical Operations stakeholders and Clinical Project Managers.

This is not a pure IT/developer position. The consultant should be able to understand business needs and translate them into system requirements and changes, while supporting the associated testing and validation activities.

Key Responsibilities:

• Support the administration, maintenance, and continuous improvement of the Veeva Vault eTMF platform.
• Serve as a functional point of contact for eTMF and Clinical Operations stakeholders.
• Gather, analyze, and translate business requirements into functional specifications and user stories.
• Support system enhancements, releases, and the implementation of new functionalities.
• Prepare and execute testing activities, including User Acceptance Testing (UAT), and manage issue resolution.
• Contribute to Computerized System Validation (CSV), change control, and GxP compliance activities.
• Provide user support and training while collaborating closely with Clinical Operations, Quality, IT, and global teams.

Requirements

• Hands-on experience with Veeva Vault eTMF and a strong understanding of eTMF processes.
• Solid knowledge of Clinical Operations within a clinical research environment.
• Experience working with computerized systems in GxP-regulated settings.
• Good understanding of Computerized System Validation (CSV) principles and activities.
• Experience managing system changes, change controls, and system lifecycle activities.
• Ability to gather business requirements and translate them into functional specifications and User Stories.
• Experience preparing, executing, and coordinating testing activities, including UAT.
• Strong communication and stakeholder management skills, with experience working in global cross-functional teams
• Fluent in English.

Benefits

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’sleading mid-size CROwith thebest employee experience. Ourone-stop provider service modeloffering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with caremeans benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.