Clinical Study Manager

Radiometer Danmark / Danaher; København; On-site; DKK 800,000 - 1,100,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Danaher Benefits Info

Job summary

Radiometer, a Danaher operating company, is seeking a Clinical Study Manager to support clinical trial execution for US and EU operations. The role focuses on regulatory compliance, harmonization of the Quality Management System (QMS) across Danaher OpCos, and drive of clinical study execution to meet milestones for new product development.

The position reports to the Senior Manager, Clinical Programs and is based on-site in Denmark, collaborating with the Clinical Development Team across

Qualifications

• Bachelor’s degree in Life Sciences or related field with 5+ years of clinical study experience, or advanced degree with reduced experience
• Experience ensuring regulatory compliance (GCP/ICH, ISO14155/20916, GDPR)
• Proven track record in study execution, data integrity, and project management for IVD/MD

Responsibilities

• Oversee planning and execution of complex clinical studies from concept to close-out
• Manage site selection, qualification, budgeting, and contract negotiations
• Review study data, site monitoring reports, and metrics to ensure data integrity and issue resolution
• Harmonize QMS across multiple Danaher operating companies under the CCoE
• Coordinate with Clinical Development Team and stakeholders across Radiometer/ Danaher

Skills

Regulatory knowledge

Project management

Stakeholder communication

Education

Bachelor's degree in Life Sciences

Master's degree

Doctoral degree

Tools

Veeva

EDC Systems

QMS tools

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Radiometer, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We’re a team that celebrates diverse ideas and continuous improvement. Here, you’ll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

Learn about the Danaher Business System which makes everything possible.

The Clinical Study Manager (on-site Denmark)

is responsible for supporting clinical trial execution within the US and EU for Danaher Diagnostics. You will be responsible for ensuring regulatory compliance, harmonization of Quality Management System (QMS) between Operation Companies (OpCo) under Clinical Center of Excellence (CCoE), and you will be responsible for driving operational execution of clinical studies, and thus achieving key milestones for our New Product Development programs.

This position reports to the Senior Manager, Clinical Programs and is part of the Clinical Study Management Team specifically supporting Radiometer Medical, an operating company within Danaher located in Copenhagen, Denmark and will be an on-site role.

In this role, you will have the opportunity to:

• Provide oversight into the planning and execution of complex In‑Vitro Diagnostic / Medical Device clinical studies (IVD / MD) from concept to close‑out, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
• Oversee site selection, including contract negotiations, qualification and budgeting
• Conduct regular reviews of clinical study data, site monitoring reports, and operational metrics to identify trends, ensure data integrity, and proactively address any performance or quality issues
• Be a part of harmonizing the QMS system across 4 operating companies under Danaher
• Communicate closely with various stakeholders in the Clinical Development Team at Radiometer, as well as the CCoE.

The essential requirements of the job include

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 5+ years related work experience or Master’s with 3+ years of related experience or Doctoral degree with 1+ year of related experience
• Demonstrate comprehensive understanding of regulatory requirements such as ISO14155, ISO20916, and FDA GCP‑ICH, and regulations like GDPR
• A minimum of 5 years of experience with study execution, data integrity, and project management principles for clinical studies within IVD/MD

Travel, Motor Vehicle Record & Physical/Environment Requirements:

if applicable for role

• The Clinical Study Manager will be collaborating with colleagues in US and should be able to accommodate the time zone differences to a certain extent

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

• Experience with Trial Master Files, Electronic Data Capture Systems, and Clinical Trial Management Systems (e.g., Veeva) would be preferred.
• Strong strategic and tactical planning skills along with strong written and verbal communication skills.
• Professional certification in Clinical Research

Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

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.

Placering

Bronshoj, Denmark, state: , cityCountry: Bronshoj, Denmark