Clinical Study Administrator

Job Title: Clinical Study Administrator

Location: Horizon Place

Introduction to role:
Are you ready to orchestrate high-quality clinical studies that help bring new cancer treatments to patients sooner? In this role, you will be the operational backbone of our study teams—ensuring every document, data point, and interaction moves trials forward at pace and to the highest standards.

You will partner closely with clinical operations, investigators, and external vendors to keep studies inspection-ready from day one. Working in a fast-moving environment that encourages smart risk-taking and clear decision-making, you will streamline processes, uphold ICH-GCP and local requirements, and enable rapid, reliable execution. Could you be the person who keeps complex studies aligned, compliant, and on schedule while our scientists push the boundaries of what’s possible?

Accountabilities:

• Study Start-up and Execution: Coordinate and administer studies from initiation through close-out, securing timely approvals and documentation to enable first-patient-in and sustain steady study momentum.
• Regulatory Submissions Support: Collect, prepare, review, and track documents for EC/IRB and, where appropriate, regulatory authorities; ensure submissions meet technical and local standards for speed and accuracy.
• Stakeholder Interface: Serve as the local administrative main contact; partner with CRAs, investigators, and vendors to remove barriers and maintain clear, consistent communication across all study sites.
• eTMF/ISF Ownership: Set up and maintain the local eTMF and ISF per ICH-GCP and local requirements; manage document tracking and version control to protect data integrity and ensure ongoing inspection readiness.
• Inspection Readiness and Compliance: Upload essential documents promptly, maintain complete, audit-ready files, and support audits and regulatory inspections in line with SOPs and policies.
• Close-out and Archiving: Ensure all documents are prepared for final archiving; support the CRA with ISF close-out activities to deliver a clean, complete study record.
• Document Authoring and Publishing: Create/import clinical-regulatory documents into global systems (e.g., ANGEL) aligned to authoring guides and Submission Ready Standards to support efficient publishing to authorities.
• Systems and Data Integrity: Set up, populate, and maintain CTMS and collaboration tools (e.g., VCV, SharePoint); coach users to ensure accurate, timely information that supports study oversight and decisions.
• Contracts and Payments: Prepare or support site-level contracts (where applicable) and manage HCO/HCP payments in accordance with local regulations, ensuring timely, compliant financial processes.
• Materials, Logistics, and Meetings: Coordinate study materials and equipment; lead logistics and contribute content for study, monitor, and investigator meetings; liaise with participants and vendors to maximize meeting outcomes.
• Communications and Translations: Prepare and distribute presentations, newsletters, and web content; ensure accurate layout and language quality, including translation and spell checks between English and local language.
• Data Management Collaboration: Interface with Data Management functions to facilitate delivery of study-related documents and materials, supporting clean, consistent data flow throughout the study lifecycle.
• Ethical and Legal Stewardship: Uphold the Code of Ethics and all company policies related to people, finance, technology, security, and SHE, as well as local, national, and regional legislation.

Essential Skills/Experience:

• Experience assisting with coordination and administration of clinical studies from start-up through execution and close-out
• Demonstrated ability to collect, prepare, review, and track documents for EC/IRB and, where appropriate, regulatory submissions in alignment with local requirements
• Proven collaboration with investigators, external service providers, and CRAs; ability to serve as the local administrative main contact throughout a study
• Hands-on experience setting up and maintaining eTMF and ISF in accordance with ICH-GCP and local regulations, including document tracking and version control
• Consistent delivery of eTMF inspection readiness through timely uploading and maintenance of essential documents
• Experience supporting ISF close-out and final archiving processes
• Ability to produce and maintain study documents with template and version compliance
• Experience creating/importing clinical-regulatory documents into global electronic management systems (e.g., ANGEL) in line with authoring standards
• Familiarity with Submission Ready Standards to support electronic publishing and delivery to regulatory authorities
• Proficiency in setting up and maintaining information in CTMS and collaboration tools (e.g., VCV, SharePoint) and supporting others in their use
• Experience preparing/supporting site-level contract preparation
• Experience preparing/supporting/performance of HCO/HCP payments in accordance with local regulations
• Experience coordinating and tracking study materials and equipment
• Experience coordinating administrative tasks during the study process, audits, and regulatory inspections, in accordance with company policies and SOPs
• Experience organizing internal and external meetings (study team, monitors, investigators) and liaising with participants/vendors
• Strong document layout and language control, including preparation and distribution of presentations, newsletters, and web content; ability to support translation and spell checks between English and local language
• Experience with printing/distribution and archiving of study/country-related emails and documents
• Experience interfacing with Data Management functions to facilitate delivery of study-related documents/materials
• Strong commitment to compliance with the Code of Ethics, company policies, and applicable legislation

Desirable Skills/Experience:

• Prior experience supporting oncology clinical trials or complex, multi-center studies
• Proficiency with Veeva Vault Clinical applications and advanced SharePoint capabilities
• Experience preparing study sites for regulatory inspections and responding to audit findings
• Track record of driving process improvements in document management and study operations
• Experience with multi-country studies and cross-cultural communication
• Advanced presentation development skills and fluency in additional languages beyond English

Why AstraZeneca?
Here you will see the direct link between meticulous study execution and faster access to life-changing treatments for people with cancer. We bring unexpected teams into the same room—clinicians, statisticians, technologists, and operations—so ideas spark and decisions accelerate. With a deep pipeline and data-rich environment, you will work at the leading edge of clinical science, from novel biomarkers to innovative trial designs. We balance ambition with support, valuing kindness alongside courage, and empower you to speak up, simplify, and take smart risks that move studies forward with speed and integrity.

Step into this role to elevate the quality and pace of pivotal studies—bring your expertise to AstraZeneca and help shape the next breakthroughs today!

Date Posted

02-Feb-2026

Closing Date

05-Feb-2026Our 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.