Leica Biosystems · 19 hours ago
Manager, Clinical Site Operations
United States
Full-time
Remote
Mid, Senior Level
$145K/yr - $170K/yr
4+ years expLeica Biosystems is a global leader in cancer diagnostics, committed to advancing cancer diagnostics and improving lives. The Manager, Clinical Site Operations is responsible for leading a team of Clinical Research Associates and overseeing clinical trial site operations, ensuring compliance with regulations and high-quality standards.
BiotechnologyMedical DeviceTherapeutics
Responsibilities
Lead and develop a team of Clinical Research Associates (CRAs), supporting their professional development and ensuring high performance
Oversee and manage clinical trial site activities within the region, including site selection, initiation, monitoring, close-out, and issue resolution, ensuring adherence to study protocols and timelines
Ensure all regional site operations activities comply with Good Clinical Practice (GCP), US FDA regulations, applicable local requirements, and company Standard Operating Procedures (SOPs)
Monitor regional site performance against key metrics (e.g., enrollment, data quality, monitoring visit frequency) and implement corrective actions as needed
Serve as the primary point of contact and escalation for CRAs and clinical sites within the region, troubleshooting operational issues
Collaborate closely with the Senior Director, Clinical Site Operations, other regional managers, and cross-functional teams (e.g., Project Management, Regulatory Affairs) to align regional activities with overall clinical strategy and goals
Contribute to the development and implementation of regional strategies, processes, and training for clinical site operations
Qualification
Required
Bachelor's Degree in field with 6+ years of experience or a Master's Degree with 4+ years of experience or PhD degree with 2+ years of experience
Two plus (2+) year leading teams and managing people
Knowledge and experience with GCP and global IVD medical device or pharmaceutical regulations
Preferred
Previous experience in the diagnostics, medical device, or pharmaceutical industry
Experience managing clinical operations or monitoring across multiple states within a US region
Experience contributing to the development or implementation of standard operating procedures or training materials
Familiarity with electronic clinical trial systems (CTMS, EDC, eTMF)
Professional certification in Clinical Research (e.g., SoCRA, ACRP)
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
Company
Leica Biosystems
Leica Biosystems develops laboratory workflow solutions for anatomic pathology involved in the advancement of cancer diagnostics. It is a sub-organization of Danaher.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ashish K. Shah
Chief Financial Officer
Emily Krach, PhD
Business Development Manager, Innovation Partnerships
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