Excelya logo
Excelya

Expertly delivering clinical trials operations, with care.

Clinical Solution Architect, eTMF

Solutions EngineerSolutions EngineerFull TimeRemoteSeniorTeam 501-1,000Since 2014H1B No SponsorCompany SiteLinkedIn

Location

France

Posted

10 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglishGoogle Cloud PlatformVault

Job Description

Clinical Solution Architect, eTMF

Excelya

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.

Job Requirements

  • 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**
  • Knowledge:**
  • 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)

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’s **leading mid-size CRO **with the **best 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.

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