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Clinical Trial Assistant – Observational Studies

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Oracle

8d ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • London

AI generated summary

  • You must have a relevant Bachelor's degree, 2 years in clinical support roles, TMF/ISF experience, strong admin skills, C1 English, MS Office proficiency, and excellent interpersonal abilities.
  • You will manage clinical trial documents, support TMF creation, ensure compliance, assist with ISF preparation, and collaborate with stakeholders for effective communication and risk mitigation.

Requirements

  • Bachelor's 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.

Responsibilities

  • 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.

FAQs

What is the job title for this position?

The job title is Clinical Trial Assistant – Observational Studies.

What type of companies does Oracle Life Sciences support?

Oracle Life Sciences empowers pharmaceutical, biotechnology, medical device companies, and clinical research organizations.

What is the primary focus of this role?

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

What is the working environment for this position?

The position offers a hybrid working model, requiring 1–2 days per week in the London office.

Is prior experience in clinical studies a requirement for this role?

Yes, prior experience supporting clinical interventional or observational studies is a mandatory requirement.

What educational background is preferred for this position?

A Bachelor's degree in Life Sciences, Healthcare Administration, or a related field, or equivalent relevant experience is preferred.

How many years of experience are required for this role?

A minimum of 2 years of experience supporting interventional or observational studies in a relevant administrative clinical research role is required.

What skills are necessary for this position?

Strong administrative, organizational, multitasking skills, exceptional attention to detail, and proficiency in Microsoft Word, Excel, PowerPoint, and document management systems are necessary.

What language proficiency is required for this job?

Outstanding spoken and written English proficiency at a minimum C1 level is required; additional languages are considered a strong asset.

What kind of support will the Clinical Trial Assistant provide?

The Clinical Trial Assistant will provide essential administrative support, including managing TMF creation and maintenance, coordinating study documentation, and ensuring compliance with quality standards.

Is Oracle an Equal Employment Opportunity Employer?

Yes, Oracle is an Equal Employment Opportunity Employer and does not discriminate against any qualified applicants based on various protected characteristics.

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Oracle

Information Technology & Services

Technology
Industry
10,001+
Employees
1977
Founded Year

Mission & Purpose

We’re a cloud technology company that provides organizations around the world with computing infrastructure and software to help them innovate, unlock efficiencies and become more effective. We also created the world’s first – and only – autonomous database to help organize and secure our customers’ data. Oracle Cloud Infrastructure offers higher performance, security, and cost savings. It is designed so businesses can move workloads easily from on-premises systems to the cloud, and between cloud and on-premises and other clouds. Oracle Cloud applications provide business leaders with modern applications that help them innovate, attain sustainable growth, and become more resilient. The work we do is not only transforming the world of business--it's helping defend governments, and advance scientific and medical research. From nonprofits to companies of all sizes, millions of people use our tools to streamline supply chains, make HR more human, quickly pivot to a new financial plan, and connect data and people around the world. At work, we embrace diversity, encourage personal and professional growth, and celebrate a global team of passionate people developing innovative technologies that help people and companies tackle real-world problems head-on.