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AstraZeneca · 1 day ago

Clinical Study Administrator

Wilmington, DE

Full-time

Onsite

Mid Level

$82K/yr - $123K/yr

3+ years exp

AstraZeneca is dedicated to improving medicine and patient outcomes. The Clinical Study Administrator (CSA) plays a crucial role in coordinating and administering clinical study activities, ensuring quality and consistency throughout the study lifecycle.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

Responsibilities

Assists in coordination and administration of clinical studies from the start-up to execution and closeout

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 LSAD 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 VCV, 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)

Qualification

Clinical Study ProcessICH-GCP guidelinesVeeva experienceDocument trackingCommunication skillsInterpersonal skillsOrganization skillsTime managementTeamwork

Required

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

Bachelor's degree with 3-5 years of experience in clinical trials and regulatory documents or similar

Must be methodical, compliant to processes yet flexible when needed

High ability to manage priorities and Local Study Team expectations

Independent yet able to work cohesively with a team

Preferred

Veeva experience a plus

Accountable and inquisitive; thinks 'outside the box'

Benefits

Qualified retirement programs

Paid time off (i.e., vacation, holiday, and leaves)

Health, dental, and vision coverage in accordance with the terms of the applicable plans

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees