Clinical Scientist
Sysmex Astrego AB / Kemiingenjörsjobb / Uppsala
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hela Sverige Sysmex Astrego is a rapidly growing in vitro diagnostic company with a commercialized diagnostic test to determine the presence of bacteria in patient samples and resistance to various antibiotics. Our mission is to shape the advancement of healthcare. We are committed to grow as a sustainable company, creating social and economic value, and providing a greater sense of security among people and the society in which they live.
Role description
In this role you will be responsible for our clinical study sites; the existing as well as independently preparing for new ones. You will closely monitor progress of our studies, follow-up on potential deviation, collaborate with our staff onsite and our external stakeholders, and ensure alignment and compliance internally with R&D.
Execute clinical study related laboratory work at Sysmex Astrego, for example reference method, colony counts, and preparation of study material.
Writing clinical validation plans, protocols, reports and related documentation required for the clinical trials.
Submissions of ethical applications and proactive communication with competent authorities for CE IVDR 2017/746 compliance.
Coordination of setting-up studies, training of operators, ensuring supply and logistic of products, qualify/monitor/support clinical study sites, and subsequent closing of sites.
Supporting development projects with identification of deviations/unexpected results in clinical studies.
Compilation of clinical study data for regulatory filing purposes.
Technical writing of Instruction For Use (IFU) and User Manual (UM).
Assisting at audits by external parties e.g. BSI.
Your profile
Bachelor or Master's degree in Microbiology
Minimum 3 years of work related experience in a similar role
Knowledge and practical experience of CE IVDR 2017/746
Experience of Good Clinical Practice (GCP), applicable standards and regulations
Experience of laboratory-based microbiological testing and data analysis
Business proficiency in English, written and spoken. Swedish is meritorious.
We offer
Sysmex Astrego is committed to creating an inclusive workplace that values diversity. We are a non-discriminatory and give every qualified candidate the opportunity to bring their expertise and valuable contributions to the team.
Among other things we offer you:
competitive compensation package
wellness allowance
work-life balance.
To find out more about working with us:
https://careers.sysmex-astrego.se/Please note that this work is onsite at our office in Uppsala. We of course offer flexible working hours in our office first approach.
About us
Sysmex Astrego AB is a fast-growing and innovative company in medical diagnostics, with a vision to develop diagnostic products to contribute to the global fight against antibiotic resistance. The company's first product is aimed at primary care for the diagnosis of urinary tract infection with suggestions for appropriate antibiotics.
Så ansöker du Sista dag att ansöka är 2023-08-10
https://careers.sysmex-astrego.se/jobs/2951727-clinical-scientist
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Sysmex Astrego AB (org.nr 559104-4671)
Vallvägen 4 B (
visa karta)
756 51 UPPSALA
Jobbnummer 7956649
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