Clinical Study Administrator
Clinical Study Associate/ Administrator (eTMF Specialist)
At AstraZeneca, we win through science, it’s at the heart of our every success. That science is only possible when we all work together – we’ll always make sure you’re clear about how your role is connected to our wider mission to really show what science can do!
The Clinical Study Associate/Administrator (CSA) assists in the coordination and administration of the study activities from Study Start Up through execution and close out, as an active member of the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. The Clinical Study Administrator will work with the electronic Trial Master File/Clinical Trial Management System (Veeva Clinical Vault) and ANGEL.
What you'll do:
- Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools (e.g.MS Teams, SharePoint, etc) and supports others in the usage of these systems.
- Operational responsibility for the correct set-up and maintenance of the local eTMF including document tracking in accordance with ICH- GCP and local requirements.
- Ensures essential documents under their responsibility are of quality and uploaded in a timely manner to maintain eTMF Inspection Readiness.
- Maintains study documents, ensuring template and version compliance.
- Interfaces with Local Study Team and CRAs during the document collection process to support effective delivery of a study and its documents.
- Ensures that all study documents are ready for final archiving and completion of the local part of the eTMF.
- 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.
- 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.
- Assumes ownership of study health for related filing artifacts in order to provide guidance and recommendations for Local Study Team.
- Works with multiple vendor systems to ensure proper access, data workflow and collection.
- Assists with the management and distribution of study team internal and external communications.
- Reviews study documents ensuring accuracy of content.
Education /Skill Requirements:
- Bachelor’s Degree in Science with 0-3 years of experience preferred/Associates degree considered with 3+ years’ of relevant experience or HS diploma with relevant experience in the Pharmaceutical industry.
- Previous document recognition experience preferably in the medical/ life science field.
- Previous experience with document management systems.
- Proven organizational and administrative skills.
- Computer proficiency.
- Good knowledge of spoken and written English.
- Further studies in administration and/or in life science field are desirable.
- Working knowledge of the Clinical Study Process and an understanding of the 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.
This is an on-site/Wilmington Office position.
Our Wilmington campus is one of 30 production facilities in 18 countries that creates life-changing medicines for people around the world. It is also the home of our North America Biopharmaceutical Business. It’s where several business functions integral to our US business are based and where 1,500 of our colleagues innovate for a higher purpose. Conveniently located near Philadelphia, our newly redesigned campus offers a positive and inclusive environment and plenty of on-site perks for employees.
AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It’s our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees’ varying needs, offers valuable choices, and is highly competitive.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.
Come and join our journey - Apply today!
Where can I find out more?
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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 authorisation and employment eligibility verification requirements.