Senior Clinical Study Manager

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, 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. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world.

Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Learn about the Danaher Business System which makes everything possible.

The Senior Clinical Study Manager is responsible for managing clinical trial execution from feasibility assessments through study closeout. This position reports to the Senior Manager Clinical Programs and is part of the Clinical Development Department located in Chaska, MN and will be an on-site role. In this role, you will have the opportunity to:

• Provide strategic oversight into the operational planning and execution of complex programs and individual In Vitro Diagnostics (IVD) clinical studies from concept to close-out, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
• Communicate potential risks and facilitate key decision-making across cross-functional teams, clinical support functions, and leadership.
• Develop and implement comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies to ensure efficient and successful study conduct.
• 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.
• Act as a key point of contact and actively support internal and external audits and regulatory inspections, ensuring timeline provision of documentation and addressing any findings or observations.

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8+ years related work experience or Masters with 6+ years of related experience or Doctoral degree with 3+ years of related experience
• Demonstrated comprehensive understanding of regulatory requirements, study execution, data integrity, and project management principles for clinical studies
• Experience working with all levels of management and consulting with key internal business stakeholders, with the proven ability to influence for greater outcome
• Strong strategic and tactical planning skills along with strong written and verbal communication skills and presentation skills

• Experience in study designs diagnostic technologies (IVD) is highly preferred, specifically for Clinical Chemistry, Immunoassays, and/or Biomarkers.
• Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs
• Professional…