OBS! Ansökningsperioden för denna annonsen har
passerat.
Arbetsbeskrivning
We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide. Join a dedicated team that's powering AstraZeneca to better serve patients, every day.
At AstraZeneca, you will be empowered to be innovative and creative where difference is valued. We thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment.
We are looking for you to come and join our Site Management & Monitoring (SMM) Nordic team in Sweden in the permanent role as Clinical Research Associate.
SMM Nordic is part of the Development Operations in the Research & Development (R&D) function. SMM performs and delivers Clinical studies in close collaboration with stakeholders in health care and academic medical institutions.
Our team will move into brand-new facilities during 2nd quarter 2022 located in Life City in Hagastaden. The new Stockholm office will bring together people from cross functional teams, in a new and vibrant workplace that facilitates innovation. It will also function as one AZ branded meeting and event location for Key External Experts, customers, partners - as well for our Nordic and Global employees.
As CRA, you will be home based, with our new Stockholm site being the connecting location of our team. We believe that you live in central or south of Sweden and are willing to go to the AstraZeneca office when needed. You also need to be able to have periods with extensive national travel and occasionally internationally.
What you'll do
At AstraZeneca, you will make a difference to patient lives every day by being responsible for the delivery of the studies at allocated centers locally. As CRA, you are a pivotal part of the Nordic Study Team and report center progress to the Nordic Local Study Associate Director (LSAD). You'll also have a close collaboration with other local CRAs and Clinical Study Administrator (CSA) to ensure quality and quantity commitments delivered in a timely and efficient manner.
Typical tasks:
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Prepare, initiate, monitor and close for an agreed number of centers and patients in clinical studies (phase I-IV) according to AZ Procedural Documents, international guidelines such as ICH-GCP and relevant local regulations
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Secure, perform and follow-up of local subject recruitment strategy and provide in-put to the Nordic recruitment strategy
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Contribute to Financial Agreements for contract development with relevant staff at the investigational site (i.e. investigator, pharmacy, and laboratory)
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Contribute to the selection of potential Principal Investigators considering capability, competence etc., of the center
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Plan and lead national Investigator meetings as applicable
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Ensure local completeness of Study Master File documentation
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Plan and lead activities associated with local audits and regulatory inspections in liaison with CQA, CQM and LSAD
Essential for the role
You have a university degree in biological science, healthcare-related field or equivalent by experience. This is complemented with at least 1-2 years of experience in the role as CRA with a very good knowledge of the clinical study and drug development processes. You need to be fluent in Swedish and English, verbally as well as in writing. Knowledge in Scandinavian languages will also be needed for the position.
You also have:
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Understanding of the clinical dataflow: knowledge of the local and Nordic Clinical Study Process and the range of working procedures relating to it. ICH/GCP guidelines are the foundation of your work.
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Excellent organization and time management skills, attention to detail, and ability to multi-task in a high-volume environment with shifting priorities
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Experience and knowledge about at least one of the following therapeutic areas; respiratory, cardiovascular or metabolism.
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Good analytical and problem-solving skills: seeing change as an opportunity to improve performance and contribute to the business
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Strong teamwork and communication skills
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Valid driving license is a requirement
Why AstraZeneca?
There are many opportunities to develop yourself and your career. From our diverse portfolio and teamwork to our ground-breaking innovations - it's a place for lifelong learning.
You will be offered a competitive salary and excellent benefits, such as extra paid Holiday, Private Medical Benefits, Company Car, wellness allowance and much, much more.
So, what's next!
Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours.
If you're curious to know more then please contact Susanne Rasmussen, phone: +45 4880 8292. We welcome your application, no later than January 9th 2022. The application period is extended due to the Christmas holiday. The applications will be reviewed continuously but we can't promise any feedback until after January 9th 2022.
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