Clinical Study Administrator
7 months ago
**Clinical Study Administrator - HN (Temporary 3 - 6 months)**
**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 Env
-
Clinical Operations Manager
6 months ago
Hanoi, Vietnam MSD Full time**Job Description**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is...
-
IT Support Administrator
6 months ago
Hanoi, Vietnam Oxford University Clinical Research Unit - Vietnam Full time**Mô tả công việc**: (Mức lương: Thỏa thuận) The post is responsible for the day-to-day operations of the IT activities in the Oxford University Clinical Research Unit - Ha Noi. He/she is also responsible for managing all servers, computers, printers, internet service, networking devices, and backup services by coordinating with IT Teams in...
-
Clinical Research Associate
7 months ago
Hanoi, Vietnam MSD Full time**Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Our company policies and procedures, quality standards and adverse event reporting requirements internally and...
-
Senior Clinical Research Associate 1
6 months ago
Hanoi, Vietnam Novasyte Full timeJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...
-
Senior Clinical Research Associate 1
6 months ago
Hanoi, Vietnam IQVIA Full timeJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...
-
Consultant RHeumatologist
6 months ago
Hanoi, Vietnam Align Recruitment Full time**Posting** ** AR-199 **Title** **Consultant Rheumatologist & Clinical Medical Director - Hanoi, Vietnam - AR-199**: **City** ** Hanoi **Country** ** Vietnam **Profession** ** Rheumatology **Job Type** ** Permanent Full-Time **Relocation** ** Yes **Salary** ** US$8,000 to $9,000 per month net after taxes paid by the employer **Start Date** **...
-
Director of Vietnamese Studies
7 months ago
Hanoi, Vietnam PERSOLKELLY Vietnam Full time**RESPONSIBILITIES**: - Create an environment that facilitates an effective shared vision; serving as a thought leader and ambassador for the school in the field of Vietnamese studies - Lead academic, research and engagement activities in the context of a broad vision of the discipline of Vietnamese studies on behalf of the school - Foster a culture of...
-
Head, Postgraduates Studies
6 months ago
Hanoi, Vietnam British University Vietnam Full time**Job Description**: - SENIOR LECTURER or ASSOCIATE PROFESSOR and HEAD, POSTGRADUATE STUDIES - Experienced academic leader with a proven track record of significant and ongoing success in developing, growing and managing a multiple post-graduate degree programme portfolio._ **BRITISH UNIVERSITY VIETNAM (BUV)** British University Vietnam (BUV) is the first...
-
Director of Studies
7 months ago
Hanoi, Vietnam IDP Education Ltd Full timeACET provides high-quality English language programs designed to prepare students for success in overseas study and their future careers. ACET was established in 2002 as a cooperation between IDP Education and UTS: Insearch, the language center of the University of Technology, Sydney. ACET operates 4 training centers in Hanoi and HCMC, with approximately...
-
Administrator
6 months ago
Hanoi, Vietnam Công ty Cổ phần Tư vấn và Giáo dục Quốc tế Việt Nam Singapore Full time**Mô tả công việc**: (Mức lương: Thỏa thuận) **Workplace** - Ciputra, Phu Thuong, Tay Ho, Hanoi (01 vacancy) - Gamuda Gardens, Yen So, Hoang Mai, Hanoi (01 vacancy) **Working Time** From Monday to Friday (8:00 to 17:00) and 2 Saturday mornings/month (9:00 to 12:00) - Reception service and telephone duties - Administrative and clerical duties;...
-
Administrator
6 months ago
Hanoi, Vietnam Faro Recruitment Vietnam JSC - HANOI HEAD OFFICE Full time**Mô tả công việc**: (Mức lương: Thỏa thuận) - To back up for the Senior Administrator in controlling all hard copies of documents of the team: receiving/ delivering the documents from/to the Consultants/internal HR/ Accounting Team; filling documents in the cabinet, inputting list of documents received/handed over in the data management...
-
Administration Assistant
6 months ago
Hanoi, Vietnam The Hong Kong Internship Platform Full time**Company Background**: Our client is a leading têxtile manufacturing company based in Asia Over 20 years history, the company specialises in producing high-quality knitted garments for international markets. With a state-of-the-art facility and a skilled workforce, our clients has built a reputation for its commitment to ethical and sustainable...
-
Website Administrator
7 months ago
Hanoi, Vietnam Positive Thinking Company Full timeAt the **Positive Thinking Company**, we are looking for your talent to strengthen and grow our community of software product engineering experts. Join a company that values you, building and growing its presence and giving you the opportunity to express your talents, share your passion and communicate your ideas. So, would you like to join **Next Practice...
-
Academic Administration Officer
6 months ago
Hanoi, Vietnam RMIT University Full timeOverview: RMIT University Commitment RMIT is committed to the rights of students and staff to be safe, respected, valued, and treated as an equal in their place of study and work. All staff are expected to share this commitment and contribute to a safer community. While carrying out their role, staff are in a position of trust with students. Staff have a...
-
Assistant Director of Studies
7 months ago
Hanoi, Vietnam IDP Education Ltd Full time**ACET, part of IDP, is seeking to recruit one Assistant Director of Studies in Hanoi.** This is an exciting opportunity at a leading EAP and IELTS provider for diploma-qualified TEFL professionals to display and develop their skills, experience, and knowledge in a full-time academic management role that includes course and material development, teacher...
-
Medical Science Liaison
8 months ago
Hanoi, Vietnam Abbott Laboratories Full time**ROLES & RESPONSIBILITIES** **RESPONSIBILITIES**: - Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to Abbott. - Ensure a strong medical and scientific presence for Abbott in key academic centers by facilitation of research and educational...
-
Business Development Executive, Toys
6 months ago
Hanoi, Vietnam Eurofins Full time**Company Description** Eurofins is Testing for Life. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing, and in discovery pharmacology, forensics, advanced material sciences and agroscience Contract Research services. Eurofins is also a market leader in certain testing and laboratory services for genomics, and in...
-
[hanoi] - Marketing Manager for Hospital Service
6 months ago
Hanoi, Vietnam NavigosSearch Full time**What We Can Offer**: - Establish marketing plans for your brand's image and service groups. - Create marketing strategies and put operational plans into place for clinics and service groups to draw clients; create estimates for the quarterly and annual marketing budgets and make sure they are allocated; and use and manage the marketing budget as...
-
[hanoi] - Marketing Manager for Hospital Service
6 months ago
Hanoi, Vietnam Navigos Search Full time**Mô tả công việc**: (Mức lương: 41 - 50 triệu VNĐ) - Establish marketing plans for your brand's image and service groups. - Create marketing strategies and put operational plans into place for clinics and service groups to draw clients; create estimates for the quarterly and annual marketing budgets and make sure they are allocated; and use and...
-
Business Development Executive, Hanoi, Vietnam
6 months ago
Hanoi, Vietnam Eurofins Full time**Company Description** Eurofins Scientific through its subsidiaries is a world leader in food, environment, pharmaceutical and cosmetic product testing, discovery pharmacology, forensics, advanced material sciences, and in agroscience Contract Research services. It is also one of the global independent market leaders in genomics and in the support of...