Senior Clinical Study Manager

Danaher Corporation

Job Overview

Location

USA - Remote

Job Type

Full-time

Full Job Description

📋 Description

• The Senior Clinical Study Manager at Danaher Corporation’s Radiometer Medical will lead clinical trial execution in the U.S., driving operational excellence and regulatory compliance for critical in-vitro diagnostic and medical device studies.
• Day-to-day responsibilities include developing and approving study protocols and informed consent forms, overseeing site selection and contract negotiations, monitoring clinical data integrity, and ensuring adherence to Good Clinical Practice (GCP) and FDA/ICH regulations across multiple complex studies.
• The role operates within Danaher’s Clinical Center of Excellence, supporting Radiometer Medical’s mission to improve global healthcare through reliable, fast, and easy patient diagnoses, with close collaboration between U.S. and European teams despite being a fully remote U.S.-based position.
• The incumbent will gain deep expertise in global clinical trial management, regulatory strategy, and cross-functional leadership while contributing to life-saving diagnostics innovation under Danaher’s Business System of continuous improvement.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Healthcare, or related field with 8+ years of related experience, or Master’s with 5+ years, or Doctoral with 3+ years
• Comprehensive understanding of regulatory requirements including ISO14155, ISO20916, FDA GCP-ICH, and GDPR
• Experience with study execution, data integrity, and project management principles for clinical studies
• Experience with Trial Master Files, Electronic Data Capture Systems, and Clinical Trial Management Systems (e.g., Veeva) preferred
• Strong strategic and tactical planning skills along with strong written and verbal communication skills

🏖️ Benefits

• Comprehensive health care programs including medical, dental, and vision insurance
• Paid time off and 401(k) retirement plan eligibility
• Flexible remote work arrangement enabled for this role
• Eligibility for bonus/incentive pay
• Access to Danaher’s broad array of competitive benefit programs supporting life beyond the job

Skills & Technologies

Angular

GCP

Senior

Remote

Degree Required

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Danaher Corporation

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About Danaher Corporation

Danaher Corporation is a global science and technology innovator headquartered in Washington, D.C. Founded in 1969, it designs, manufactures, and markets medical, industrial, and commercial products and services to professional, medical, and scientific customers. Operating through three segments—Life Sciences, Diagnostics, and Environmental & Applied Solutions—Danaher owns brands such as Beckman Coulter, Cepheid, Leica Microsystems, and Hach. The company applies the Danaher Business System, a continuous-improvement methodology, to drive quality, delivery, cost, and innovation. With approximately 63,000 associates worldwide, Danaher focuses on accelerating diagnostics, advancing life-science research, and ensuring water quality and public health.

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