Senior Clinical Study Manager

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.

• 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.

• 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.

• 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).

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.

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