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We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives.

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Clinical Study Manager(On-Site Denmark). This role will be responsible for our internal blood donor programs in Denmark and Finland and will support our clinical trial execution within the US and EU regions for Danaher Diagnostics. This role will specifically support Radiometer Medical, an operating company of Danaher Diagnostics. You will be responsible for communication with ethical committees and other national authorities, ensuring daily compliance with our internal verification and validation activities within Radiometer, but also clinical studies conducted outside the facility. You will have an advisory role for the Danaher worldwide blood and tissue program and play a key role for the European landscape.

This position is part of Danaher Diagnostics, Radiometer Medical and will be located on-site at our facility in Copenhagen (Brønshøj).

In this role, you will have the opportunity to:

• Ensure compliance within the blood donor programs and verification and validation studies conducted internally at Radiometer.

• Communicate closely with various internal stakeholders at Radiometer, such as R&D, Operations, Facility Service, and the Regulatory and Quality Affairs departments.

• Communicate with external stakeholders, including ethical committees and national competent authorities.

• Contribute to the development and writing of study protocols and other essential documents for clinical studies, and submit the study package, including the informed consent form, for ethical approval.

• Update and develop quality instructions, ensure the review process is followed, and maintain consistency and compliance with our Quality Management System. Furthermore, participate in internal and external audits.

• Participate in the initiation of external study sites, monitor study data during execution, follow up with study sites on data collection issues, and proactively address these issues.

The essential requirements of the job include:

• Master’s degree in Life Sciences, Healthcare, or a related field with 5+ years related work experience or Doctoral degree with 2+ year of related experience. Demonstrated comprehensive understanding of regulatory requirements such as ISO14155, ISO20916, and FDA GCP-ICH, and regulations like GDPR. Experience with study execution, data integrity, and project management principles for clinical studies.

• Experience with ethical committee submissions and actively supported submission strategy

• Furthermore, experience with Trial Master Files, Electronic Data Capture Systems, and Clinical Trial Management Systems would be preferred.

• Working with all levels of key internal stakeholders and consulting with external stakeholders.

• Strong strategic and tactical planning skills along with strong written and verbal communication skills and presentation skills

It would be a plus if you also possess previous experience in:

• Experience in study designs for in-vitro diagnostic and/or medical devices is highly preferred

• Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs

• Professional certification in Clinical Research.

• Danish language skills

Application

We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application. The recruitment will be completed as soon as a suitable candidate is found.

We look forward to seeing your application.

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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.