Global Study Associate (GSA)

Granta Park, UK or Gaithersburg, US

Salary: Competitive

We’re passionate about the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really change the course of medicine and bring big new ideas to life.

The Global Study Associate (GSA) supports delivery of early-phase global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the study team with coordinating activities and with ensuring quality & 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 & standard methodologies and AZ values & behaviours.

The exact accountabilities will differ depending on the nature of the clinical study so you'll need a high degree of flexibility. You may work across many different studies and delivery models concurrently.

Accountabilities:  

• Set-up, maintain and close the Trial Master File (TMF) as delegated and ensure its compliance to ICH-GCP and AZ SOPs.
• Interact/collaborate with internal and external partners in collection of regulatory and other crucial documents/information. 
• Coordinate the collection, review and track relevant study documents in TMF.
• Support production of study documents (as delegated), ensuring template and version compliance per study-specific requirements.
• Set-up, populate and accurately maintain information in AZ tracking & communication tools and support team members in the usage of these tools
• Contribute to and distribute meeting material and other varied forms of communication
• Coordinate administrative tasks and logistic support throughout the conduct of the study, as well as during audits and regulatory inspections.
• Support the study team by completing other delegated study work as required.

Essential requirements:

• Administrative knowledge and basic knowledge in drug development and ICH-GCP
• Validated organisational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
• Ability to prioritise 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 requirements:

• Bachelor’s Degree (or higher)
• Education in medical or biological sciences or subject area associated with clinical research
• Study administration experience
• Experience within the pharmaceutical industry
• Experience in supporting clinical trials and study development.

Closing date: 26th October 2020.

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.