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

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.

• 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.

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.

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.

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.

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.

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, nationality, ethnic or social origin, age, religion, political orientation, sexual orientation, gender identity/expression,

family or marital status, pregnancy, disability, or any other basis prohibited by law.

CellaVision® was established in Sweden in 1994 with a vision to simplify, standardize, and digitize the manual analysis of blood

cells in hematology laboratories. The company’s long-term success is a result of our commitment to innovation. Our goal is to

provide value to patients, customers and distributors by incorporating smart solutions into everything we do. Our research and

development focus on offering superior analytical and diagnostic certainty by creating an ecosystem that combines reagents with

hardware and software. Today CellaVision has 250 employees, with global Headquarters in Lund, Sweden.

The company has market support offices in 16 markets and a presence in over 40 countries with reagent development and

manufacturing performed in Martillac, France.