Senior Clinical Study Manager

Danaher Corporation

2d•Remote

About The Position

The Senior Clinical Study Manager will be responsible for clinical trial execution within the US for Danaher Diagnostics, specifically supporting Radiometer Medical. This role involves driving operational execution, ensuring regulatory compliance, and achieving key milestones for critical clinical studies in the US. The position reports to the Senior Manager Clinical Programs, Clinical Development, within the Clinical Center of Excellence at Danaher Diagnostics. This is a fully remote role within the United States, requiring close collaboration with U.S. and European teams and the ability to work across time zones.

Requirements

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.
Strong strategic and tactical planning skills along with strong written and verbal communication skills.

Nice To Haves

Experience with Trial Master Files, Electronic Data Capture Systems, and Clinical Trial Management Systems (e.g., Veeva) would be preferred.
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.

Responsibilities

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.