[Hiring] Senior Clinical Study Manager @Danaher Corporation

Role Description

The Senior Clinical Study Manager will be responsible for clinical trial execution within the US for Danaher Diagnostics, specifically supporting Radiometer Medical. You will drive operational execution, ensure regulatory compliance, and achieve key milestones for critical clinical studies in the US.

This position reports to the Senior Manager Clinical Programs, Clinical Development, part of the Clinical Center of Excellence within Danaher Diagnostics. 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.

In this role, you will have the opportunity to:

• Contribute to study‑level and program‑level strategy, governance, and decision‑making.
• Drive operational excellence initiatives across the clinical studies portfolio.
• Develop, review, and approve study protocols, informed consent forms, and other essential clinical study documents.
• 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.
• Ensure adherence to protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.
• Lead and oversee site selection strategy, including contract negotiations, site qualification, and budget oversight.
• Perform high‑level reviews of clinical study data, site monitoring outputs, and operational metrics.
• Identify systemic trends, ensure data integrity, and proactively resolve performance, quality, or compliance issues.
• Participate in the initiation of external study sites and monitor study data during execution.
• Communicate closely with various stakeholders in the clinical team.

Qualifications

• 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+ years of related experience.
• 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 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.

Requirements

• 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.

Benefits

• Comprehensive, competitive benefit programs.
• Health care program.
• Paid time off.
• Medical/dental/vision insurance.
• 401(k) to eligible employees.
• Remote work arrangement eligible.
• Annual salary range of 120,000-150,000 USD.
• Eligible for bonus/incentive pay.