Senior Clinical Study Manager

Danaher Corporation•Chaska, MN

1d•$125,000 - $135,000•Onsite

About The Position

The Senior Clinical Study Manager is responsible for managing clinical trial execution from feasibility assessments through study closeout. This position reports to the Senior Manager Clinical Programs and is part of the Clinical Development Department located in Chaska, MN and will be an on-site role. In this role, you will have the opportunity to: 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 timeline provision of documentation and addressing any findings or observations.

Requirements

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

Nice To Haves

Experience in study designs 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).

Responsibilities

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 timeline provision of documentation and addressing any findings or observations.