Global Study Associate

Do you have expertise in, and passion for, administration and organizational tasks combined with knowledge in drug development and clinical trials? Are you team oriented and do you, as we do, put patients first in your work to make a difference? Then AstraZeneca might be the right place for you to contribute and thrive.

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.

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.

We are recruiting for a Global Study Associate who will join our Study Management Cardiovascular Renal Metabolic Diseases (CVRM) team - which forms part of BioPharmaceuticals Clinical Operations . The position will be based in one of our vibrant R&D sites, either in Gothenburg, Sweden or in Gaithersburg, US.

Study Management CVRM, are accountable for delivering high quality, cost efficient clinical studies (phase 1 to phase 3) that support drug development within Cardiovascular Renal Metabolism (CVRM).

We expect employees to be on-site for a minimum of three days per week and will therefore be unable to offer remote based working.

What you'll do:
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.

The responsibilities will also include:

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Support the GSD, GSAD and/or GSM by completing delegated study work as required. May work across multiple studies and delivery models concurrently.
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Set-up, maintain and close the Trial Master File (TMF) as delegated by the GSD/GSAD, ensuring compliance to ICH-GCP and AZ SOPs.
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Interact/collaborate with internal and external stakeholders in collection of regulatory and other essential documents/information.
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Oversee the collection, review and track relevant study documents in the TMF.
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Support production of study documents (as delegated), ensuring template and version compliance per study-specific requirements.
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Contribute to and distribute meeting material and other varied forms of communication.
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Contribute to electronic applications/submissions by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities.
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Collate the administrative appendices for the Clinical Study Report.
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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 Requirements:

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

To succeed in the role, we also believe that you are team oriented and have ability to prioritize appropriately and manage multiple deliverables. You can also work independently and have good communication, collaboration and interpersonal skills.


Desirable Requirements:

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Bachelor's degree (or higher)
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Education in medical or biological sciences or discipline associated with clinical research
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Study administration experience
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Experience within the pharmaceutical industry
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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.

We offer competitive salary and benefits.

So, what's next?

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. We welcome your application, no later than October 2nd.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.