Senior Clinical Research Associate
AstraZeneca AB / Biomedicinjobb / Stockholm
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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 BioPharmaceutical Clinical 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.
In May 2022 our team moved into brand-new facilities in Life City in Hagastaden. The new Stockholm office bring together people from cross functional teams, in a new and vibrant workplace that facilitates innovation. It will also function as one AstraZeneca branded meeting and event location for Key External Experts, customers, partners - as well for our Nordic and Global employees.
As a CRA, you will be field based, with the Stockholm site as 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 health care and academic medical institutions. As CRA, you are a pivotal part of the Nordic Study Team and report progress in the studies 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 3 years of experience in the role as CRA hereof at least 1 year of experience in Risk-Based-Monitoring. You must have 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, gastrology, metabolism or infectious diseases
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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, wellness allowance and much, much more.
So, what's next!
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 July 7th 2023.
Due to the holiday season, responses to your application will not be sent until August 2023.
Where can I find out more?
Our Company
https://www.astrazeneca.com/our-company.htmlWhat Science can do
https://www.youtube.com/watch?v=pmFx_jr2eFoInclusion & diversity at AstraZeneca
https://www.astrazeneca.com/sustainability/ethics-and-transparency/inclusion-and-diversity.html Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2023-07-07
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-169879".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
birgitta.nystrom@astrazeneca.com Jobbnummer 7929363
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