Senior Clinical Study Manager

Danaher Corporation

Senior Clinical Study Manager responsible for clinical trial execution and strategy oversight. Ensuring adherence to regulatory standards for IVD studies within US and EU regions.

Posted 5/29/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $120,000 - $150,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.
Oversee site and vendor selection and management activities for clinical trial services, ensuring contracts, scope of work, and performance metrics align with study objectives and Standard Operating Procedures (SOPs).
Develop and implement comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies to ensure efficient and successful study conduct - this includes the development and writing of clinical study protocols, informed consent forms, and other essential study documents, ensuring scientific rigor and operational feasibility.
Establish and maintain robust communication channels with investigators, site staff, internal stakeholders, and external partners to facilitate smooth study progress and timely issue resolution.
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.
The individual will 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.

Requirements

What you’ll need

Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8 + years work experience or Master’s degree with 6+ years of related experience
Demonstrated comprehensive understanding of regulatory requirements, study execution, data integrity, strategic and tactical planning, written and verbal communication, 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
Direct experience with Immunohistochemistry (IHC) operational workflows
Ability to work in a global environment

Benefits

Comp & perks

Paid time off
Medical/dental/vision insurance
401(k)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

In Vitro Diagnostics (IVD)Good Clinical Practice (GCP)Standard Operating Procedures (SOPs)clinical study protocolsinformed consent formsdata integrityImmunohistochemistry (IHC)project managementstrategic planningtactical planning

Soft Skills

communicationinfluenceproblem-solvingcollaborationleadershiporganizational skillsstakeholder managementissue resolutionadaptabilitycritical thinking