Location Bangkok, Bangkok, Thailand
Job ID R-233763
Date posted 19/08/2025
Clinical Study Administrator Fixed-term 1-year contract
Job Summary: The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start-up to execution and close-out, and within the Local
Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.
Typical Accountabilities:
- Assists in the coordination and administration of clinical studies from the start-up to execution and close-out.
- Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate, to Regulatory Authorities for the duration of the study.
- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
- Serves as the local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
- Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF, including document tracking by ICH-GCP and local requirements.
- Ensures essential documents under their responsibility are uploaded promptly to maintain the eTMF “Inspection Readiness”.
- Ensures that all study documents are ready for final archiving and completion of the local part of the eTMF and supports the CRA in the close-out activities for the ISF.
- Contributes to the production and maintenance of study documents, ensuring template and version compliance.
- Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL), ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents.
- Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.
- Sets up, populates and accurately maintains information in AstraZeneca tracking and communication
- tools (e.g., CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (except countries where there is a specific role dedicated to setting up and updating the systems).
- Prepares and/or supports contract preparation at a site level (except for countries where there is a specific role dedicated to preparing site contracts).
- Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments following local regulations.
- Manages and contributes to the coordination and tracking of study materials and equipment.
- Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
- Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes.
- Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.
- Responsible for layout and language control, copying and distribution of documents. Supports with
- local translation and spell checks in English to/from local language, as required.
- Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country-related e-mails.
- Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions
- representatives to facilitate the delivery of study-related documents/material.
- Ensures compliance with AstraZeneca’s Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Ensures compliance with local, national and regional legislation, as applicable.
Qualification:
- High school/Secondary school qualifications (*), that support skills and capabilities of the position and ensure successful conduct of responsibilities and appropriate interactions with internal and or external customers.
- Previous administrative experience, preferably in the medical/ life science field.
- 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
- Ability to develop advanced computer skills to increase efficiency in daily tasks.
- Proven organizational and administrative skills.
- Good interpersonal skills and ability to work in an international team environment.
- Computer proficiency.
- Good knowledge of spoken and written English.
Date Posted
20-ส.ค.-2025Closing Date
30-ส.ค.-2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.