Clinical Trial Assistant – Observational Studies

Description

Oracle Life Sciences empowers pharmaceutical biotechnology medical device companies and clinical research organizations to bring therapies to market faster and more efficiently. We are helping organizations accelerate innovation and improve health outcomes for patients worldwide.

With ongoing and ground-breaking developments in Oncology and Rare Disease an increased focus on more scientific targeted medicine and continuous integration of technology into development and delivery of medicine there has never been a more exciting time to join us!

We are currently seeking a highly organized and detail-oriented Clinical Trial Assistant (CTA) to provide
essential administrative support
to our clinical project teams.

This role is heavily focused on clinical documentation Trial Master File (TMF) management and coordination activities supporting observational research programs.

Working Environment

Hybrid working model:
12 days per week in the London office.

Please note:
Prior experience supporting clinical interventional or observational studies is a mandatory requirement.

What you will do

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

Required Experience

• Bachelors degree (preferably in Life Sciences Healthcare Administration or a related field) or equivalent relevant experience.
• Mandatory:
  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). Additional languages are considered a strong asset.
• 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.

Career Level - IC2

Required Experience:

Junior IC