Senior Clinical Studies Associate

TL;DR

Senior Clinical Studies Associate (MedTech): Overseeing the end-to-end clinical trial process for new diagnostic products with an accent on protocol development, site management, and regulatory compliance. Focus on coordinating cross-functional teams to launch products, managing clinical specimen acquisition, and ensuring data integrity for peer-reviewed publications.

Location: Must be based in Stillwater, Minnesota, USA

Salary: $87,500–$108,000 annually

Company

A global leader in immunodiagnostic and molecular diagnostic solutions dedicated to advancing science and improving patient outcomes.

What you will do

• Identify and evaluate potential external clinical trial sites through detailed investigations and site visits.
• Collaborate on the development of clinical trial protocols and manage contract negotiations with external collaborators.
• Act as the primary liaison between the company and external sites for data exchange, IRB/HIPAA compliance, and technical reporting.
• Monitor site performance, including reviewing procedures and data, and provide necessary on-site training.
• Coordinate cross-functional teams across R&D, manufacturing, and marketing to support product launches and pre-market positioning.
• Maintain cost accounting and management systems for external test and clinical trial sites.

Requirements

• Bachelor's Degree required (RN is a plus; Master's or Doctorate preferred).
• 5+ years of experience in IVD and 5+ years of experience in laboratory medicine.
• Proven ability to communicate effectively with external collaborators and clients.
• Strong knowledge of regulatory standards and ability to interpret technical procedures and governmental regulations.
• Proficiency in project management, time management, and data analysis.
• Must be eligible to work in the United States and subject to background checks.

Culture & Benefits

• Comprehensive health benefits package including medical, dental, and vision.
• Retirement and financial wellbeing programs.
• Annual incentive program based on individual and organizational performance.
• Commitment to a people-centered culture that values inclusion and continuous development.
• Opportunities to contribute directly to solutions that improve patient care worldwide.