Clinical Study Administrator

2 weeks ago

Hanoi, Hanoi, Vietnam AstraZeneca Full time

Clinical Study Administrator - HN

About AstraZeneca and AstraZeneca Vietnam


AstraZeneca is a global, science-led biopharmaceutical company with a British-Swedish heritage that focuses on the discovery, development, and commercialization of prescription medicines.

At AstraZeneca, science and patients are at the heart of everything we do.

Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Established in 1994, AstraZeneca Vietnam has come a long way in 27 years of advancing Vietnam's healthcare.

We change lives through innovative science with $25mil in R&D investment ; 40 ongoing clinical trials with 2800+ patients; 44 partnered hospitals and 14 medicines involved in trials.

We have built strong public-private partnerships for sustainability and healthcare access through many programs and activities such as Healthy Lung, Young Health Program, Careme, Giá Như, Health System Sustainability & Resilience, Green Energy for Health, Response to Covid-19.

We have gained some recognition for our efforts from the Minister of Health's Certificates of Merits for outstanding contributions to advancing cancer treatment and exceptional contributions to Vietnam's fight against COVID ; BritCham 2021 Awards for Contributions to healthcare and 25+ years of service in Vietnam; Ho Chi Minh Communist Youth Union's Medal and Certificate of Merit for contributions to youths (2021); Excellent Leadership - Visionary Leader Award (2021); HR Excellence - Workplace Culture Award and Vietnam's Top 100 Places to Work Award

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 startup to execution and closeout.
  • 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 setup 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 clinicalregulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents.
  • Setsup, 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 websites.
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