Clinical Study Administrator
AstraZeneca

Job Description

The Clinical Study 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. This is an on-site/Wilmington Office position.

Position Duties:

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

Education /Skill Requirements:

• Bachelor's Degree/Associate's Degree preferred or equivalent experience that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interaction with internal and or external customers.
  
• 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.
  

Preferred:

• 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.
  

Global Career Level

C

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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