Global Study Associate

2 weeks ago

Mississauga, Canada AstraZeneca Full time

**Global Study Associate**

**Mississauga, CA; Warsaw, PL; Gothenburg, SE or Barcelona, ES**

**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 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.
- 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 until the 29th January 2023.

**Where can I find out more?

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