Senior Clinical Study Manager

Beckman Coulter Diagnostics; Chaska (MN); On-site; USD 125,000 - 135,000; Full time

Benefits offered by this job

Comprehensive benefits package

Paid time off

401(k)

Job summary

Beckman Coulter Diagnostics is seeking a Senior Clinical Study Manager for an on-site role in Chaska, MN. The position involves overseeing complex In Vitro Diagnostics clinical studies, ensuring compliance with GCP and regulatory standards. The ideal candidate should have a Bachelor's degree with extensive experience in clinical study management and a strong understanding of project management principles.

The role offers an annual salary range of $125,000–$135,000 and is eligible for bonus pay. A comprehensive benefits package is available including 401(k) and medical insurance.

Qualifications

• 8+ years of related work experience with a Bachelor's degree.
• Strong understanding of regulatory requirements for clinical studies.
• Experience influencing management and consulting key stakeholders.

Responsibilities

• Provide oversight for IVD clinical studies from concept to close-out.
• Maintain data integrity and address performance issues.
• Develop comprehensive study operational plans.

Skills

Strategic planning

Communication skills

Project management

Regulatory compliance

Risk mitigation

Education

Bachelor's degree in Life Sciences or related field with 8+ years experience

Master's degree with 6+ years experience

Doctoral degree with 3+ years experience

Job description

Senior Clinical Study Manager

Location: Chaska, MN. This is an on-site role reporting to the Senior Manager Clinical Programs in the Clinical Development Department.

In This Role

• Provide strategic oversight into the operational planning and execution of complex programs and individual In Vitro Diagnostics (IVD) clinical studies from concept to close‑out, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
• Communicate potential risks and facilitate key decision‑making across cross‑functional teams, clinical support functions, and leadership.
• Develop and implement comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies to ensure efficient and successful study conduct.
• Conduct regular reviews of clinical study data, site monitoring reports, and operational metrics to identify trends, ensure data integrity, and proactively address any performance or quality issues.
• Act as a key point of contact and actively support internal and external audits and regulatory inspections, ensuring timely provision of documentation and addressing any findings or observations.

The Essential Requirements Of The Job Include

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8+ years related work experience, or Masters with 6+ years of related experience, or Doctoral degree with 3+ years of related experience.
• Demonstrated comprehensive understanding of regulatory requirements, study execution, data integrity, and project management principles for clinical studies.
• Experience working with all levels of management and consulting with key internal business stakeholders, with the proven ability to influence for greater outcomes.
• Strong strategic and tactical planning skills along with strong written and verbal communication skills and presentation skills.

It Would Be a Plus If You Also Possess Previous Experience In

• Study designs for diagnostic technologies (IVD) is highly preferred, specifically for Clinical Chemistry, Immunoassays, and/or Biomarkers.
• Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
• Professional certification in Clinical Research (e.g., SoCRA, ACRP).

Salary and Benefits

The annual salary range for this role is $125,000–$135,000. This role is eligible for bonus/incentive pay. We offer a comprehensive benefits package that includes paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.

EEO Statement

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here.