Clinical Affairs Monitor

CellaVision is a global leader in digital microscopy, delivering complete solutions that combine advanced instruments, reagents, and software to support healthcare services worldwide. Our vision is clear: To elevate healthcare through the evolution of microscopy – in a sustainable way. We work at the forefront of technology and use many of the latest advances in programming, chemistry, digital imaging, and machine learning. Joining our company means that you will play an essential role in elevating healthcare through the evolution of microscopy. Location: Lund, Sweden Job type: Full Time, Permanent How you will contribute The overall purpose of the Clinical Affairs Monitor is to ensure effective execution, monitoring, and documentation of clinical studies and post-market clinical activities. Through close collaboration with external study sites and internal stakeholders, you will build strong relationships, coordinate study activities, and help keep studies on track. By providing support, guidance, and proactive follow-up, you will contribute to high-quality clinical data, regulatory compliance, and the generation of reliable clinical evidence for CellaVision's products. As a Clinical Affairs Monitor you will, for example: · Build and maintain strong relationships with study sites, acting as a trusted point of contact throughout the study lifecycle. · Monitor pre-clinical studies, clinical performance studies, and post-market clinical performance studies, including site qualification, initiation, monitoring, and close-out visits, as well as follow-up of deviations and corrective actions. · Support study sites through training, regular communication, and proactive follow-up on study progress, sample collection, and documentation. · Performing first line data review, including case report forms, verification of data completeness and ensuring sample traceability. · Coordinate study logistics such as sample shipments, instrument installations, study databases, data transfers, and maintenance of study documentation. · Establish and maintain Trial Master Files (TMF) and Trial Site Files (TSF). · Contribute to the preparation of all study-related documentation, together with Clinical Affairs Specialists. You will be part of the Clinical Affairs team, currently consisting of four Clinical Affairs specialists and one Cell Morphology Expert. The team works closely together in a collaborative and supportive environment to achieve shared goals. What you will bring The person stepping into this role enjoys working with people and building strong relationships, while also being highly organized and detail oriented. As a Clinical Affairs Monitor, you will collaborate closely with external laboratories and study sites, helping them stay engaged, informed, and on track throughout the study process. You are a positive and proactive communicator who can establish trust, coordinate activities across multiple stakeholders, and motivate others to deliver high-quality results within agreed timelines. You take initiative, follow up on commitments, and approach challenges with a solution-oriented mindset. You understand the importance of working in a regulated environment and have an interest in clinical research and medical devices. Your ability to apply relevant regulations, procedures, and quality standards will help ensure that studies are conducted compliantly and generate reliable clinical evidence. You are also comfortable working with technical systems and software and enjoy investigating and solving practical issues. You can confidently perform basic software installations and configuration tasks, review log files and use tools such as Excel to verify and analyze clinical study data. What we are looking for · B.Sc. degree or equivalent in a relevant scientific, biomedical, or healthcare-related field · Experience within medical devices, clinical research, healthcare, or quality assurance · Knowledge of medical device regulations, including ISO 13485 and IVDR or MDR · Knowledge of ISO 14155 and Good Clinical Practice (GCP) is considered an advantage · Strong communication and interpersonal skills · Excellent organizational skills and ability to manage multiple activities simultaneously · Good computer skills, including software installation, database management, log file review, and data verification in Excel · Advanced level of English, written and verbal What we offer CellaVision has a world-leading position in digital cell morphology and we see our employees as our primary resource for our ongoing innovation and success. Joining CellaVision means that you will surround yourself with over 250 employees that are both passionate and ambitious. We believe that an open and friendly company culture along with employees that take initiative and responsibility is what makes us grow together. We have created an innovative working environment in a flat organization with an open-minded attitude and ability for our employees to make quick and sound decisions. We can offer you a varied, exciting and occasionally challenging work with a lot of responsibility and a great deal of freedom. This is a full-time position primarily based on-site at CellaVision’s HQ in Lund, Sweden, with the flexibility to work remotely one to two days per week. The position may require approximately 20-30 traveling days yearly. Ready to apply? Apply as soon as possible via our career site. We will work with continuous selection and interviews, so please send your application as soon as possible. We do not accept applications via email. Diversity is in our blood At CellaVision we understand not only the uniqueness of blood cells but also of people. We strongly believe in the power of diversity and recognise it as a driver of innovation. We are committed to building an inclusive culture for all our people. CellaVision is a non-discriminatory workplace where qualified applicants receive consideration for employment without regard to race, na