Clinical Study Administrator

Clinical Study Administrator - HCM

The ideal candidate is a passionate, self-motivated, and detail-oriented team player who is committed to the success of our customers. Then AstraZeneca might be the one for you!

About AstraZeneca and AstraZeneca Vietnam

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

AstraZeneca Vietnam

As a Foreign Invested Enterprise with over 600 members, AstraZeneca is investing into Vietnam 360 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 – 2024) with various other industry awards from BritCham, EuroCham, and government agencies..

What you’ll do

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.

• 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 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.

• 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 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.
• 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 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 compliance with local, national and regional legislation, as applicable.

Additional country-specific tasks might be added depending on local needs.

Education, Qualifications, Skills and Experience

Essential

• High school/Secondary school qualifications (*), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
• Previous administrative experience preferably in the medical/ life science field.
• Proven organizational and administrative skills.
• Computer proficiency.
• Good knowledge of spoken and written English.

(*) to be adapted to local country market needs.

Desirable

• Further studies in administration and/or in life science field are desirable (*)
• 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.
• Good verbal and written communication.
• Good interpersonal skills and ability to work in an international team environment.
• Willingness and ability to train others on study administration procedures.
• Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Integrity and high ethical standards.

Key stakeholders and relationships

Internal (to AZ or team)

• Local Study Team including Local Study Managers and CRAs
• Line Manager (ADSMM and local SMM LT)
• Clinical Quality Manager
• Global Study Teams
• Local Regulatory Affairs
• Enablement functions

* Medical Department personnel if CSA supports local studies (as per agreement by CH/CD and Medical Director)

External (to AZ)

• Investigators and site personnel
• Study related vendors
• ECs/ IRB
• Regulatory Authorities

Be bold and make a powerful impact: AstraZeneca is a world-leading business where standards are high and challenges complex, but also a collective where we build, support and motivate each other. This unique combination of strong expectation and empowerment invites you to improve how our markets work and make your individual mark. Here, you can follow your ambitions with full confidence. As part of a responsible, value-led business with a strong sustainability agenda, you can also help impact the future beyond business projects.

Be part of our growth journey and success story: Join the fastest growing pharmaceutical company in our markets, set up to fuel further growth. Make the most of our assets: our strong heritage, our early investment and commitment in emerging markets, and how we embrace digital and data to transform the patient journey. Go beyond your limits. Welcome failure as a chance to learn. There’s no better place to feel inspired, energised and try new things.

Learn and grow by embracing diverse opportunities: Experience an organisation where professional development is prized and nurtured. Access the tools and support you need to continuously learn. Then it’s up to each of us to step up, speak up and show what we can do. Take advantage of working in a global business with opportunities to move beyond your role and open international doors. At AstraZeneca, your future is in your own hands.

Urgently bring our leading pipeline to millions of patients in need: Seize the opportunity to help improve the lives of millions of patients, including in areas where patient needs are often unmet. Work with our transformative pipeline to help bring a variety of high-quality medicines to market – and ensure they are made easily accessible to as many patients as possible.

Be heard in a culture of local empowerment: AstraZeneca is set up for creativity. We encourage unity and ownership at a local level, with collaboration across the global organisation. We tailor how we work, adapting to our markets and healthcare systems. In our diverse community, every voice is important. Share your ideas and opinions openly. In our speak-up culture, the way we communicate with each other leads to more powerful innovation.

So, what’s next?

If you’re curious to know more then please take initiative to recruitment.Vietnam@astrazeneca.com. We encourage your application.

Where can I find out more?

Visit our website www.astrazeneca.vn

Follow us on LinkedIn www.linkedin.com/company/astrazeneca/ and Facebook https://www.facebook.com/AstraZenecaVN

Contact us via recruitment.Vietnam@astrazeneca.com

Date Posted

Closing Date

AstraZeneca 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.