Senior Clinical Study Lead – IVD Trials & Compliance

Radiometer; Chaska (MN); On-site; USD 125,000 - 135,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Clinical Study Manager in Chaska, MN for an on-site role. You will manage clinical trial execution from feasibility to close-out, ensuring GCP compliance and regulatory adherence.

You will develop study plans, monitor timelines and budgets, coordinate cross-functional teams, and support audits and inspections to ensure quality and compliance.

Qualifications

• Bachelor’s degree or higher in Life Sciences or related field with 8+ years of related experience, or Master’s with 6+ years, or Doctoral degree with 3+ years.
• Strong understanding of regulatory requirements, study execution, data integrity, and project management.
• Experience influencing senior stakeholders and communicating across functions.

Responsibilities

• Provide strategic oversight into operational planning and execution of complex IVD clinical studies from concept to close-out.
• Communicate risks and facilitate key decision-making across cross-functional teams and leadership.
• Develop and implement study plans including timelines, budgets, resources, and risk mitigation.
• Review clinical study data, site monitoring reports, and metrics to ensure data integrity and address issues.
• Support internal and external audits and regulatory inspections with timely documentation.

Skills

Regulatory knowledge

Study execution

Project management

Stakeholder influence

Communication skills

Education

Bachelor's in Life Sciences

Master's degree

Doctoral degree

Job description

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Clinical Study Manager in Chaska, MN for an on-site role. You will manage clinical trial execution from feasibility to close-out, ensuring GCP compliance and regulatory adherence.

You will develop study plans, monitor timelines and budgets, coordinate cross-functional teams, and support audits and inspections to ensure quality and compliance.