Senior Clinical Study Manager

About the Role Senior Clinical Study Manager is responsible for managing clinical trial execution from feasibility assessments through study closeout. This on-site role reports to the Senior Manager Clinical Programs and is part of the Clinical Development Department, located in Chaska, MN. What You'll Do

• 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. What We're Looking For
• 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 outcome.
• Strong strategic and tactical planning skills along with strong written and verbal communication skills and presentation skills.
• Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
• Professional certification in Clinical Research (e.g., SoCRA, ACRP). Nice to Have
• Experience in study designs diagnostic technologies (IVD) is highly preferred, specifically for Clinical Chemistry, Immunoassays, and/or Biomarkers.
• Be cept this line as part of Nice to Have items: Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
• Professional certification in Clinical Research (e.g., SoCRA, ACRP). Compensation & Benefits
• Salary range: $125,000 - $135,000 per year.
• Be part of Beckman Coulter Diagnostics, a Danaher operating company, with a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees.