Clinical Solution Architect eTMF

Excelya; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Excelya is seeking an eTMF Specialist to ensure quality, compliance, and inspection readiness of the electronic Trial Master File across global trials. The role requires expertise in clinical documentation management, collaboration with cross‑functional teams, and active involvement in audits within a regulated environment, with a focus on ICH‑GCP and regulatory standards.

You will lead Veeva Vault TMF configurations, validation activities, data migrations, and training to enable seamless study

Qualifications

• Bachelor’s or Master’s degree in Health Sciences, Life Sciences, or related field.
• Strong experience in clinical trial documentation management.
• Hands-on experience with Veeva Vault TMF (mandatory).
• Strong understanding of the DIA TMF Reference Model.
• Experience with TMF metrics, KPIs, and dashboards.
• Strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Understanding of clinical trial documentation lifecycle.
• Knowledge of cross-functional stakeholders (Clinical, QA, PV, Biometry, etc.).
• Excellent collaboration and communication skills across global teams.

Responsibilities

• Led implementation and configuration of Veeva Vault Clinical apps (eTMF, CTMS, SSU, Payments, Site Connect).
• Facilitated requirements workshops and translated business needs into compliant system solutions.
• Designed and configured Vault solutions aligned with clinical operations and regulatory requirements.
• Managed system validation activities, including test planning, UAT coordination, defect tracking, and compliance documentation.
• Oversaw data migration and system integration projects, ensuring data quality and interoperability.
• Developed and delivered end-user and administrator training programs for user adoption.
• Advised stakeholders on best practices, configuration options, and optimization of processes.
• Partnered with client project teams to ensure delivery and compliance with ICH-GCP and GxP standards.

Skills

Veeva Vault TMF

DIA TMF Reference Model

TMF metrics & dashboards

ICH/GCP regulatory knowledge

Clinical trial documentation lifecycle

Cross-functional collaboration

Audit & inspection readiness

Education

Bachelor’s or Master’s degree in Health Sciences/Life Sciences

Tools

Veeva Vault TMF

Job description

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.

The eTMF Specialist plays a key role within the Clinical Development Platform by ensuring the quality, compliance, and inspection readiness of the electronic Trial Master File (eTMF) across global clinical trials.

This role requires strong expertise in clinical documentation management, close collaboration with cross‑functional teams, and active involvement in audits and inspections within a regulated environment.

Key Responsibilities

• Led the implementation and configuration of Veeva Vault Clinical applications, including eTMF, CTMS, Study Startup (SSU), Payments, and Site Connect.
• Facilitated requirements gathering workshops and translated business needs into scalable and compliant system solutions.
• Designed and configured Vault solutions aligned with clinical operations processes and regulatory requirements.
• Managed system validation activities, including test planning, UAT coordination, defect tracking, and compliance documentation.
• Oversaw data migration and system integration projects, ensuring data quality and seamless interoperability with external systems.
• Developed and delivered end-user and administrator training programs, supporting user adoption and change management initiatives.
• Advised stakeholders on best practices, configuration options, and alternative solutions to optimize business processes and system performance.
• Partnered closely with client project teams across global pharmaceutical companies and SMEs to ensure successful project delivery and compliance with ICH‑GCP and GxP standards.

Education

Bachelor’s or Master’s degree in Health Sciences, Life Sciences, or related field

Experience

Strong experience in clinical trial documentation management

Technical Skills

• Hands‑on experience with Veeva Vault TMF (mandatory)
• Strong understanding of the DIA TMF Reference Model
• Experience with TMF metrics, KPIs, and dashboards
• Strong knowledge of ICH/GCP guidelines and regulatory requirements
• Understanding of clinical trial documentation lifecycle
• Knowledge of cross‑functional stakeholders (Clinical, QA, PV, Biometry, etc.)

Languages

Fluent English (written and spoken)

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. Our one-stop provider service model - offering 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 care means 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.