Senior Clinical Study Manager (IVD)

Location: USA - Remote

Salary: $120,000–$150,000 annually, plus bonus or incentive pay.

Company

Leica Biosystems is a hirify.global Diagnostics operating company developing diagnostic solutions across the cancer care pathway, from biopsy to diagnosis.

What you will do

• Lead end-to-end planning and operational delivery of complex IVD clinical studies from concept through close-out.
• Ensure study execution follows protocols, Good Clinical Practice, regulatory requirements, timelines, and quality standards.
• Manage clinical trial site and vendor selection, contracts, scopes of work, performance metrics, and standard operating procedures.
• Develop study operational plans covering timelines, budgets, resources, and risk mitigation, including clinical protocols and informed consent forms.
• Coordinate investigators, site staff, internal stakeholders, and external partners to resolve issues and deliver program milestones.
• Review clinical data, monitoring reports, and operational metrics, and support audits and regulatory inspections.

Requirements

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8+ years of experience, or a master’s degree with 6+ years of related experience.
• Comprehensive understanding of regulatory requirements, clinical study execution, data integrity, strategic and tactical planning, communication, and project management.
• Experience working with all levels of management and influencing internal business stakeholders.
• Direct experience with Immunohistochemistry operational workflows.
• Ability to work in a global environment.

Nice to have

• Experience designing studies for IVD technologies, particularly Companion Diagnostics, Computational Pathology, IHC, or ISH.
• Advanced degree in Science, Healthcare, Regulatory Affairs, or Clinical Affairs.
• Professional clinical research certification such as SoCRA or ACRP.

Culture & Benefits

• Collaborative global environment focused on innovation and continuous improvement.
• Paid time off and comprehensive medical, dental, and vision insurance.
• 401(k) benefits for eligible employees.
• Eligibility for bonus or incentive pay.