Clinical Study Administrator

Job Title: Clinical Study Administrator

Location: Luton, UK

Salary: Competitive + Excellent Employee Benefits!

Applications Deadline: July 27

Introduction to role:
Are you ready to make a significant impact in the fight against cancer? As a Clinical Study Administrator, you'll play a crucial role in coordinating and administering clinical study activities from start-up to close-out. Join our dedicated team and ensure quality and consistency in delivering interventional study objectives on time, within budget, and to the highest standards.

Accountabilities:

• Assist in coordination and administration of clinical studies from start-up to execution and close-out.

• Collect, prepare, review, and track documents for the application process; ensure timely submission to EC/IRB and Regulatory Authorities.

• Interface with Investigators, external service providers, and CRAs to support effective study delivery.

• Serve as local administrative contact, working closely with CRAs and LSAD throughout the study.

• Maintain local eTMF and ISF, ensuring document tracking compliance with ICH-GCP and local requirements.

• Ensure essential documents are uploaded promptly for eTMF “Inspection Readiness.”

• Prepare study documents for final archiving and support CRA in ISF close-out activities.

• Contribute to production and maintenance of study documents, ensuring template and version compliance.

• Import clinical-regulatory documents into Global Electronic Management System, adhering to AstraZeneca Authoring Guide.

• Handle clinical-regulatory documents for electronic applications/submissions, supporting effective publishing to regulatory authorities.

• Set up, populate, and maintain information in AstraZeneca tracking tools; support others in system usage.

• Prepare/support contract preparation at site level; manage HCO/HCP payments per local regulations.

• Coordinate and track study materials and equipment.

• Manage administrative tasks during study process, audits, and regulatory inspections per company policies.

• Lead practical arrangements for internal/external meetings; liaise with participants/vendors.

• Prepare and distribute presentation material for meetings, newsletters, and websites.

• Handle layout control, translation, printing, distribution, and archiving of study-related documents/emails.

• Interface with Data Management Centre to facilitate delivery of study-related documents/materials.

• Ensure compliance with AstraZeneca’s Code of Ethics, company policies, and applicable legislation.

Essential Skills/Experience:

• High school/Secondary school qualifications that support skills and capabilities of the position.

• Previous administrative experience preferably in the medical/life science field.

• Proven organizational and administrative skills.

• Computer proficiency.

• Good knowledge of spoken and written English.

Desirable Skills/Experience:

• Further studies in administration and/or life science field are desirable.

• Working knowledge of the Clinical Study Process and understanding of ICH-GCP guidelines.

• Ability to develop advanced computer skills for increased efficiency.

• Good verbal and written communication skills.

• Strong interpersonal skills; ability to work in an international team environment.

• Willingness to train others on study administration procedures.

• Excellent organization, time management skills, attention to detail, and ability to multi-task.

• Team-oriented and flexible; ability to respond quickly to shifting demands.

• Integrity and high ethical standards.

AstraZeneca is a place where courage, curiosity, and collaboration thrive. We are driven by patient outcomes and empowered to lead at every level. Our pioneering approach combines cutting-edge science with the latest technology to achieve breakthroughs in oncology. With a commitment to transforming lives, we aim to eliminate cancer as a cause of death. Join us in making bold decisions that write the next chapter for our pipeline.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• Ready to take action? Apply now to be part of our transformative journey!

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

18-Jul-2025

Closing Date

26-Jul-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.