Clinical Study Administrator

Location: Luton

Join AstraZeneca as a Clinical Study Administrator and help us deliver life-changing medicines.

In this role you will assist in the coordination and administration of the clinical study activities and work within the Local Study Team (LST) to ensure quality and consistency of study deliverables to time, cost and quality objectives.

This is a varied clinical administration role where you will get involved beyond the documentation, and will get exposure to administrative support of all aspects of clinical trials from start to finish.

Our clinical studies span a range of therapeutic areas including respiratory, oncology, cardiovascular and metabolic diseases. You will play an important role in all stages of a clinical study including set up, maintenance and close down activities, and you will have regular communication with hospital trusts and sites as well as key internal stakeholders. It’s a role with lots of scope to learn and progress.

Responsibilities

You will assist in coordination and administration of clinical studies from start-up to execution and close-out.

Specific tasks could include:

• Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors

• Assisting in preparation, review and tracking of documents for the application process (RA/IEC).

• Interfacing with Investigators, external service provider and Clinical Research Associates (CRAs) during the collection process to support effective delivery of a study and its documents.

• Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File (ISF) including tracking of documents, ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.

• Contributing to the production and maintenance of study documents, ensuring template and version compliance.

Essential requirements

• Previous administrative experience preferably in the medical/ life science field.

• Experienced user of Microsoft Office suite: Word / Excel / Powerpoint etc

• Excellent communication skills

• 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

• Good interpersonal skills and ability to work in an international team environment

• Display 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 work well under pressure and to respond quickly to shifting demands and opportunities

Desirable requirements:

• Previous administrative experience gained within a healthcare / pharmaceutical environment (for example as a clinical trials administrator)

• Qualification in administration and/or degree in a scientific subject

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.