Clinical Study Manager

In our line of work, life isnât a given - itâs the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world weâre located. Creating impactful innovations like ours, doesnât happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career. 

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, weâre working at the pace of change to improve patient lives with diagnostic tools that address the worldâs biggest health challenges. 

The Clinical Study Manager at Radiometer is responsible for completing clinical studies globally in a range of different product areas throughout the product lifecycle, and to proactively connect with relevant internal and external partners on a global level.

This position is part of the Clinical and Medical Affairs function located in Brønshøj, Copenhagen and will be hybrid position. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Clinical Affairs team and report to the Director of Clinical Operations responsible for clinical study execution in all Radiometer business areas. If you thrive in a dynamic and fast-growing environment and want to work to build a world-class clinical study organization - read on.

In this role, you will have the opportunity to:

• Collaborate with other functions (data management, statistics, medical writing, clinical research, medical affairs, quality, research and development and marketing) as well as external partners (investigators, subject matter experts, Contract Research Organizations) on study deliverables.
• Proactively identify clinical project risks, provide input to appropriate countermeasures and contingency plans, and assure implementation of action plans to reduce project risk.
• Together with your more senior colleagues in the team, you ensure program requirements are met and that clinical studies are executed in a compliant, scientifically appropriate manner.
• Be highly involved in clinical study planning and study design. Examples of deliverables that you will be involved or be responsible for include the development of clinical protocols, monitoring plans, and Trial Master Files.
• Drive study execution and site management: Directly or through a network of internal and external (CRO/CRA) colleagues, you will provide ad-hoc support to sites and investigators to ensure timely completion of the studies. This may include site visits from site initiation to monitoring and closing.

The essential requirements of the job include:

• A Master of Science in a scientific, biological, or medical science field.
• Some direct and hands-on experience (1-3 years) in clinical study conduct.

It would be a plus if you can demonstrate:

• A strong track record of successful results in clinical operations.
• Experience with in-vitro diagnostic devices such as clinical biochemistry or immunoassays.
• Experience with studies in international settings, including towards the US FDA.

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

Application

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Hybrid

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide. 

Danaher

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.