Global Study Associate - Neuroscience

Cambridge, UK

Competitive salary and benefits

Make a more meaningful impact to patients’ lives around the globe

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

With deep roots and a proud heritage, AstraZeneca is a well-known brand and respected company, with a strong reputation in both the scientific community and academia.

The Global Study Associate (GSA) supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the Global Study Director (GSD), Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency. The GSA supports with administration & systems and with other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & best practices and AZ values & behaviours.

Typical accountabilities

• Support the GSD, GSAD and/or GSM by completing delegated study work as required. May work across many different studies and delivery models concurrently.

• Set-up, maintain and close of the Trial Master File (TMF) as delegated by the GSD/GSAD. Ensure compliance to ICH-GCP and AZ SOPs.

• Interact/collaborate with internal and external stakeholders in collection of regulatory and other essential documents/information.

• Oversee the collection, review and track relevant study documents in the TMF.

• Support production of study documents (as delegated), ensuring template and version compliance per study-specific requirements.

• Contribute to and distribute meeting material and other varied forms of communication.

• Contribute to electronic applications/submissions in ANGEL by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Collate the administrative appendices for the Clinical Study Report.

• Set-up, populate and accurately maintain information in AZ tracking and communication tools (e.g. CTMS, SharePoint, MS Teams etc.) and support team members in the usage of these tools.

Essential criteria

• Administrative knowledge and basic knowledge in drug development and ICH-GCP

• Proven organizational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment

• Ability to prioritize appropriately and to be adaptable

• Computer proficiency in day-to-day tasks

• Excellent verbal and written communication in English

• Demonstrate ability to work independently, as well as in a team environment

Desirable criteria

• Bachelor’s degree (or higher)

• Education in medical or biological sciences or discipline associated with clinical research

• Study administration experience

• Experience within the pharmaceutical industry

• Experience in supporting clinical trials and study development

Why AstraZeneca

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.

So, what’s next?

This role is open from 6th July to the 13th July 2022.

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.