Clinical Research Scientist

The Clinical Research Scientist leads the execution of clinical studies that make up the company’s clinical evidence generation program. The role involves collaborating with cross-functional teams to generate impactful clinical evidence that supports the company’s strategy.

Requirements

• Bachelor degree required in scientific, medical, or healthcare discipline
• 2+ years of professional related experience in clinical trial management, preferably in diagnostics or medical device
• Certifications including ACRP-CP or ACRP-PM a plus
• Excellent knowledge of clinical trial processes, systems, and tools (e.g., CTMS, EDC, eTMF), with the ability to oversee quality, data integrity, and inspection readiness
• Proven leadership and stakeholder-management capabilities, with the ability to influence without authority and build strong relationships across functions and with external partners
• Experience negotiating clinical research contracts and budgets
• Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
• Experience managing all major aspects of strategic planning, organization, implementation, and delivery of clinical studies
• Understanding the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO)
• Proven track record writing clinical study plans and study protocols
• Experience with the study budget oversight, risk mitigation, management of timelines, deliverables, and milestones
• Experience negotiating clinical research contracts and budgets with Investigators and sites
• Experience with electronic clinical trial systems and clinical data review

Benefits

• Choice of medical, dental, and vision plans
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves