Global Study Associate (12 Month Contract)

Global Study Associate (12 month contract)

Multiple Openings

Mississauga, Canada (hybrid work- average of 3 days in office)

Competitive Salary And Benefits

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

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Job Summary

The Global Study Associate (GSA) supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. You will support 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

• Interact/collaborate with internal and external partners in collection of regulatory and other documents/information.
• Set-up, maintain and close the Trial Master File (TMF) as delegated by the GSD/GSAD. Ensure compliance to ICH-GCP and AZ SOPs.
• Handle the collection, reviewing, and tracking of relevant study documents in the TMF.
• Support production of study documents (as delegated), ensuring template and version compliance per study-specific requirements.
• 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, 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.
• 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.

Essential Criteria

• Demonstrate ability to work independently, as well as in a team environment
• Ability to prioritize appropriately and to be adaptable
• Administrative knowledge and basic knowledge in drug development and ICH-GCP
• Computer proficiency in day-to-day tasks
• Organizational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
• Excellent verbal and written communication in English

Desirable criteria

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

Great People want to Work with us! Find out why:

• Learn more about working with us in Canada
• View our YouTube channel
• GTAA Top Employer Award for 9 years
• Learn about our culture

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected]