Senior Clinical Study Manager (IVD)

Location: Chaska, Minnesota, United States; on-site role

Annual salary: $125,000–$135,000, plus bonus or incentive pay.

Company

Beckman Coulter Diagnostics, a hirify.global operating company, develops clinical diagnostic solutions used in hospitals, reference and research laboratories, and physician offices worldwide.

What you will do

• Provide strategic oversight for operational planning and execution of complex IVD clinical programs and individual studies from concept through closeout.
• Ensure adherence to study protocols, Good Clinical Practice, and regulatory requirements.
• Develop study plans covering timelines, budgets, resource allocation, and risk mitigation.
• Communicate risks and support decision-making across cross-functional teams, clinical functions, and leadership.
• Review clinical study data, site monitoring reports, and operational metrics to identify trends and address quality issues.
• Support internal and external audits and regulatory inspections, including documentation and remediation of findings.

Requirements

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8+ years of related experience; or a master’s degree with 6+ years; or a doctoral degree with 3+ years.
• Comprehensive understanding of regulatory requirements, clinical study execution, data integrity, and project management principles.
• Experience working with all levels of management and internal business stakeholders, with the ability to influence outcomes.
• Strong strategic and tactical planning, written and verbal communication, and presentation skills.

Nice to have

• Experience designing studies involving diagnostic technologies, particularly Clinical Chemistry, Immunoassays, or Biomarkers.
• Advanced degree in Science, Healthcare, Regulatory Affairs, or Clinical Affairs.
• Professional clinical research certification such as SoCRA or ACRP.

Culture & Benefits

• Work within a culture focused on belonging, innovation, and continuous improvement.
• Comprehensive benefits package for eligible employees.
• Paid time off and medical, dental, and vision insurance.
• 401(k) plan.