Clinical Research Associate
AstraZeneca AB / Sjukhusteknikerjobb / Södertälje
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hela Sverige Do you have experience of clinical studies and drug development processes? Are you looking for your next position? At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
We are looking for you to come and join our Site Management & Monitoring (SM&M) Nordic team in Gärtuna, Sweden in the permanent role as Clinical Research Associate.
SM&M Nordic is part of the Development Operations in the Research & Development (R&D) function. SM&M executes and delivers Clinical studies. Sweden contribute with a substantial part of the SM&M Nordic delivery. Clinical studies are delivered in close collaboration with stakeholders in health care and academic medical institutions.
What you'll do:
At AstraZeneca you will make a difference to patient lives every day. In this role, by being responsible for the delivery of the studies at allocated centers locally. As Clinical Research Associate you will actively participate in the SM&M Nordic study team and have close collaboration with the Nordic Local Study Manager (LSM), other local CRAs and Clinical Study Administrator (CSA) to ensure quality and quantity commitments delivered in a timely and efficient manner.
Plan and lead national Investigator meetings as applicable - and ensure local completeness of Study Master File documentation. When introducing new CRA's and CSA's, you will participate in training and mentoring for the new team members.
Tasks in the position;
* 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.
* Secure, perform and follow-up of local subject recruitment strategy and provide in-put to the Nordic recruitment strategy.
* Contribute to Financial Agreements for contract development with relevant staff at the investigational site (i.e. investigator, pharmacy, and laboratory).
* Proactively identify and facilitate resolution at local level of complex study problems and issues.
* Plan and lead activities associated with local audits and regulatory inspections in liaison with CQA, CQM and LSM.
Essentials in the role:
* University degree in biological science or healthcare-related field, or equivalent by experience
* Experience as a Clinical Research Associate
* Good understanding of the clinical dataflow: good knowledge of the local and Nordic Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
* Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities
* Good analytical and problem-solving skills: seeing change as an opportunity to improve performance and add value to the business
* Very good knowledge of the clinical study and drug development processes, including also risked based monitoring.
* Extensive experience and knowledge about the therapeutic areas within Oncology.
We also believe that the successful candidate has great computer skills and a good understanding of required IT system. Good language skills in Swedish and English, both verbal and written and ability to periods of extensive travel nationally and occasionally international travel. You also need to have a driving license. Good communication skills are important, and we hope you are a person who enjoys teamwork and working in a collaboration environment.
Why AstraZeneca?
When we see an opportunity for change, we seize it and make it happen, because any opportunity can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey in finding new ways to work, pioneering cutting edge methods and bringing unexpected teams together!
If this sound like your next challenge, we look forward to welcome you to our team!
Please send in your application no later than 13th December 2020.
More information:
For more information please contact recruiting manager Britta Murray Eriksson, phone: +46 (0)709 154047.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2020-11-09ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2020-12-07
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-092830".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 5435594
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