Clinical Trial Assistant – Observational Studies

Oracle Oracle · Enterprise · LONDON, United Kingdom

This role provides essential administrative support to clinical project teams, focusing on clinical documentation, Trial Master File (TMF) management, and coordination activities supporting observational research programs. The ideal candidate will have a strong background in clinical trial documentation management and administrative support within the life sciences sector.

What you'd actually do

  1. Supporting Trial Master File (TMF) creation and maintenance.
  2. Managing the set-up, organization, processing, and archiving of all clinical trial documents throughout all project phases.
  3. Assisting in the preparation and delivery of Investigator Site Files (ISF).
  4. Ensuring compliance and quality standards for documentation and participating in file audits.
  5. Collaborating closely with internal and external stakeholders to ensure effective communication and risk mitigation related to document management.

Skills

Required

  • Bachelor's degree or equivalent relevant experience
  • Minimum 2 years of experience supporting interventional or observational studies in a Clinical Trial Assistant, Study Coordinator, Site Coordinator, or similar administrative clinical research role
  • Demonstrated experience with clinical trial documentation management, including Trial Master Files (TMF) and Investigator Site Files (ISF)
  • Strong administrative, organizational, and multitasking skills with exceptional attention to detail
  • Experience coordinating study documentation, tracking deliverables, and supporting audit readiness activities
  • Outstanding spoken and written English proficiency (minimum C1 level)
  • Proficiency in Microsoft Word, Excel, PowerPoint, and document management systems
  • Excellent interpersonal and customer service skills with the ability to work effectively across cross-functional teams
  • Proactive, dependable, and committed to delivering high-quality administrative support in a fast-paced environment

Nice to have

  • Additional languages are considered a strong asset

What the JD emphasized

  • Prior experience supporting clinical interventional or observational studies is a mandatory requirement.