Q-linea continues to grow and is now looking to recruit a Clinical Study Manager to join the company. Q-linea develops and delivers innovative solutions for the diagnosis of infectious diseases, with a keen focus on improving sepsis treatment while reducing antibiotic resistance. The company’s leading product, ASTar®, is a fully automated instrument for antimicrobial susceptibility testing (AST), which produces a sensitivity profile from a positive blood culture in approximately six hours. This is 24 to 40 hours faster than current diagnostics.
As a Clinical Study Manager, you will have a key role in the Clinical study team and help bring about a new reality of faster phenotypic AST that allows healthcare providers to accurately diagnose and treat infectious diseases in the shortest possible time. In this role, you will have the opportunity to contribute to studies to gain CE mark and FDA clearance for new products. We are looking for an outgoing clinical trial regulatory expert, who wants an exciting position at a company in the forefront of innovative infectious disease diagnostics.
Q-linea has its HQ in Uppsala Sweden and is listed on the Nasdaq Stockholm Mid Cap. The position is full-time and preferably based in Stockholm or Uppsala, Sweden. We welcome your application today!About the position
As a Clinical Study Manager, you will be part of the Clinical Study team inside the Clinical Value Department at Q-linea and report directly to Clinical Study Leader at the company.
Duties and responsibilities include:
• Prepare and manage study protocols and study documentation related to clinical studies in compliance with IVDR, FDA, good study/clinical practice, and applicable standards and guidelines.
• Prepare Independent Ethics Committee/ Institutional Review Board (IEC/IRB) submissions.
• Interact with internal and external stakeholders such as investigational sites, clinical consultants, Contract Research Organizations in a professional manner.
• Support the Clinical Study Leader with the development of clinical study plans and their execution, and other study related documentation in the TMF with support from internal Regulatory Affairs/CRO partners.
• Support the Clinical Study Leader with the preparation of SOPs related to study organization and management.
• Stay updated on the relevant procedures and standards linked to the role.Your profile
The suitable candidate has the following qualifications:
• BSc or higher (MSc, PhD) degree within Life Sciences
- 3+ years’ experience in working in connection with clinical studies for regulatory purposes within the medical device space in Europe and/or the USA.
- Fluent in English, both written and oral
The ideal candidate for this position is self-motivated, result-driven, and has a strong ability to collaborate in internal and external teams. Strong communication and time management skills are key to succeed in this role. Furthermore, we believe that you are a “quick on your feet” and have an eye for details.
If you are ready to bring your skills and expertise to this position, we are ready to offer you an exciting and dynamic work environment with internal and external stakeholders where you will make a key difference and help patients get better clinical outcomes!About the organisation
Q-linea AB is a public-listed diagnostic company focused on developing and delivering solutions to enable healthcare providers to diagnose and treat infectious diseases in the shortest possible time. Our vision is to help save lives by, as an innovative pioneer, ensuring that antibiotics can be maintained as an effective treatment for future generations. The company was founded in 2008 around technology developed by researchers from the Rudbeck Laboratory at Uppsala University, together with Olink Bioscience AB and Uppsala University's holding company UUAB. Q-linea today consists of a 100+ interdisciplinary and highly motivated team that conducts its operations in modern and well adapted premises in Uppsala Science Park and in Fyrislund. You can find more information about Q-linea at www.qlinea.com