Clinical Study Administrator - 12 Month FTC

Horizon Place, Luton, UK

Salary & Benefits competitive

Be empowered to be innovative and creative where difference is valued!

Join a company built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

AstraZeneca UK is proud to provide the scientific knowledge and scale behind medicines and vaccines that improve the lives of millions of people around the world.

Our belief powers us to push the boundaries. As we improve success rates, we keep moving forward. Celebrating both successes and failures along the way!

What you’ll do

• Assist in the coordination and administration of clinical studies from the start-up to execution and close-out.

• Assist Local Study Manager (LSAD) with ongoing study approval process by ensuring timely collection of trial documentation from sites required for Ethics and Regulatory Authorities for the duration of the study.

• Work with Investigators, external service providers and Trial Monitors (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.

• Ensure 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.

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

• 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.

• Prepares/supports/performs site payments in accordance with site contracts and local process.

• Leads the coordination and tracking of study materials and equipment.

• Coordinates administrative tasks during all study process and site audits and/or regulatory inspections, according to company policies and SOPs.

• Leads the practical arrangements and supplies 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, supplies to and distributes presentation material for meetings, newsletters and web-sites as appropriate.

• Responsible for layout and language control, copying and distribution of documents. Supports with local translations to support patient recruitment, inclusion and diversity, as appropriate.

• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails.

• Working with Data Management Centre and/or Data Management, Global Clinical Solutions 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.

Essential Criteria

• 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.

Desirable Criteria

• Bachelors degree in related subject area, preferably in life science, or equivalent qualification.

• Previous experience in a clinical study administrator role

• 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.

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Date Posted

18-Mar-2024

Closing Date

22-Mar-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.