Senior Clinical Study Manager

Senior Clinical Study Manager Location: USA - Remote 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 Senior Clinical Study Manager will be responsible for clinical trial execution within the US for Danaher Diagnostics. This role will specifically support Radiometer Medical, an operating company within Danaher Diagnostics. You will be responsible for driving operational execution, ensuring regulatory compliance, and achieving key milestones for critical clinical studies in the US. This position reports to the Senior Manager Clinical Programs, Clinical Development which is a part of Clinical Center of Excellence within Danaher Diagnostics, supporting Radiometer Medical. While Radiometer’s main facilities and clinical leadership are based in Denmark, this is a fully remote role within the United States, with close collaboration across U.S. and European teams and the ability to work across time zones is expected. In this role, you will have the opportunity to: Contribute to study‑level and program‑level strategy, governance, and decision‑making, and drive operational excellence initiatives across the clinical studies portfolio. Responsible for the development, review, and approval of study protocols, informed consent forms, and other essential clinical study documents, and ensure timely submission of the complete study package for IRB/EC approval. Provide overall oversight for the planning and execution of multiple complex In‑Vitro Diagnostic / Medical Device (IVD/MD) clinical study programs from concept to close‑out, with accountability for ensuring adherence to protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. Lead and oversee site selection strategy, including responsibility for contract negotiations, site qualification, and budget oversight. Perform high‑level reviews of clinical study data, site monitoring outputs, and operational metrics to identify systemic trends, ensure data integrity, and proactively resolve performance, quality, or compliance issues. 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. Communicate closely with various stakeholders in the clinical team, such as Clinical Research Scientist, Clinical Research assistants, and Clinical Study Manager Lead. The essential requirements of the job include: Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8+ years related work experience or Master’s with 5+ years of related experience or Doctoral degree with 3+ year of related experience. Demonstrate 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 is a given. 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. It would be a plus if you also possess previous experience in: Experience in study designs for diagnostic technologies (IVD) is highly preferred Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs 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. At Radiometer, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide. The annual salary range for this role is 120,000-150,000 USD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. #LI-LM3 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. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.