Clinical Study Administrator

**Clinical Study Administrator - HCM**

**About AstraZeneca and AstraZeneca Vietnam**

**AstraZeneca**

**AstraZeneca Vietnam**

As a Foreign Invested Enterprise with over 550 members, AstraZeneca is investing into Vietnam 310 million USD from 2020 to 2030 with a focus on reducing the burdens of non-communicable diseases, developing local talent, and uplifting the domestic biopharmaceutical R&D and manufacturing capabilities.

Over the last three decades accompanying Vietnam’s sustainable development, AstraZeneca has run several impactful programmes in collaboration with the Government, Ministry of Health and healthcare partners to promote disease awareness, prevention and early detection. In recent years, AstraZeneca Vietnam has received several certificates of merit from the Prime Minister and Minister of Health, for excellent contributions to Vietnam’s vaccine diplomacy, fight against COVID-19 and advancement of cancer treatment and disease awareness. The company has also been recognized among Vietnam’s Top 100 Best Places to Work (2018 - 2022) with various other industry awards from BritCham, EuroCham, and government agencies.

**What you’ll do**:
**Short role description**

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.
- CSAs might have different internal titles based on the experience level (CSA, Senior CSA). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The SMM Country Head may assign this internal title after confirmation with Cluster Director SMM/Senior Director SMM (Region). This will only be applicable for countries which have been exempted to use tiered internal titles._

**Typical Accountabilities**
- Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
- 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 local administrative main contact and works closely with the CRAs and/or the LSM for the duration of the study.
- 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.
- Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
- Ensures that all study documents are ready for final archiving and completion of 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.
- Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools (e.g. CTMS such as IMPACT, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).
- Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
- Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
- Manages and contributes to 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 web-sites.
- 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.
- Interfaces with Data Management Centre and/or Data Management Enablement 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 com