Clinical Study Administrator

Job Title: Clinical Study Administrator

Introduction to role:

Are you passionate about clinical research and eager to contribute to groundbreaking studies? As a Clinical Study Administrator (CSA), you will play a crucial role in coordinating and administering study activities from start-up to close-out. Join our Local Study Team (LST) to ensure the quality and consistency of interventional study deliverables, meeting time, cost, and quality objectives.

Accountabilities:

1. Assist in coordination and administration of clinical studies from start-up to execution and close-out.
2. Collect, assist in preparation, review, and track documents for the application process. Ensure timely submission of proper application/documents to EC/IRB and, where appropriate, to Regulatory Authorities for the duration of the study.
3. Interface with Investigators, external service providers, and CRAs during the document collection process to support effective delivery of a study and its documents.
4. Serve as the local administrative main contact and work closely with the CRAs and/or the LSAD for the duration of the study.
5. Maintain operational responsibility for the correct set-up and maintenance of the local eTMF and ISF, including document tracking in accordance with ICH-GCP and local requirements.
6. Ensure essential documents under your responsibility are uploaded in a timely manner to maintain the eTMF 'Inspection Readiness'.
7. Ensure all study documents are ready for final archiving and completion of the local part of the eTMF, supporting the CRA in close-out activities for the ISF.
8. Contribute to the production and maintenance of study documents, ensuring template and version compliance.
9. Create and/or import clinical-regulatory documents into the Global Electronic Management System (e.g., ANGEL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents.
10. Contribute to electronic applications/submissions by handling clinical-regulatory documents according to requested technical standards (i.e., Submission Ready Standards), supporting effective publishing and delivery to regulatory authorities.
11. Set up, populate, and accurately maintain information in AstraZeneca tracking and communication tools (e.g., CTMS such as VCV, SharePoint) and support others in using these systems.
12. Prepare and/or support contract preparation at a site level.
13. Prepare/support/perform Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
14. Manage and contribute to coordination and tracking of study materials and equipment.
15. Coordinate administrative tasks during the study process, audits, and regulatory inspections according to company policies and SOPs.
16. Lead practical arrangements and contribute to the preparation of internal and external meetings (e.g., study team meetings, Monitors' meetings, Investigators' meetings). Liaise with internal and external participants/vendors in line with international and local codes.
17. Prepare, contribute to, and distribute presentation material for meetings, newsletters, and websites.
18. Responsible for layout and language control, copying, and distribution of documents. Support local translation and spell checks in English to/from local language as required.
19. Responsible for printing and distribution of documents such as letters and meeting minutes, handling, and archiving of study/country-related emails.
20. Interface with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study-related documents/material.
21. Ensure compliance with AstraZeneca's Code of Ethics and company policies/procedures relating to people, finance, technology, security, and SHE (Safety, Health, and Environment).
22. Ensure compliance with local, national, and regional legislation as applicable.

1. High school/Secondary school qualifications that support skills and capabilities of the position and ensure successful conduct of responsibilities and appropriate interactions with internal/external customers.
2. Previous administrative experience preferably in the medical/life science field.
3. Proven organizational and administrative skills.
4. Computer proficiency.
5. Good knowledge of spoken and written English.

1. Further studies in administration and/or life science field are desirable.
2. Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH-GCP guidelines.
3. Ability to develop advanced computer skills to increase efficiency in daily tasks.
4. Good verbal and written communication.
5. Good interpersonal skills and ability to work in an international team environment.
6. Willingness and ability to train others on study administration procedures.
7. Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.
8. Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities.
9. Integrity and high ethical standards.

At AstraZeneca, we are driven by our passion for science. We are committed to making a difference by treating, preventing, modifying, or even curing some of the world's most complex diseases. Our inclusive environment fosters collaboration across academia, biotechs, and industry. We embrace lifelong learning opportunities that allow us to grow our knowledge while making a significant impact on patients' lives globally. Here you can build a meaningful career while pushing the boundaries of science.

Ready to make a difference? Apply now!

So, what's next?

Please complete your application before the below closing date (29th April 2025).

We look forward to hearing from you.