Senior Clinical Study Manager

Job not on LinkedIn

🕒 May 29

🇺🇸 United States – Remote

💵 $120k - $150k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Danaher Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

🔬 Science

🤝 B2B

Biotechnology • Science • B2B

Danaher Corporation is a leading global life sciences and diagnostics innovator that develops and supplies instruments, technologies, software, and services to accelerate scientific research, biotechnology development, and clinical diagnostics. The company operates through businesses focused on biotechnology tools, diagnostics platforms, and life sciences products, leveraging the Danaher Business System and an acquisition-driven strategy to scale technologies and support customers across academia, pharmaceutical and biotech companies, and clinical laboratories.

📋 Description

• 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

• 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

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