Clinical Study Manager (On-Site US)
About The Position
The 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: Oversee site and vendor selection and management activities for clinical trial services, ensuring contracts, scope of work, and performance metrics align with study objectives and Standard Operating Procedures (SOPs). Develop and implement comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies to ensure efficient and successful study conduct. Establish and maintain robust communication channels with investigators, site staff, internal stakeholders, and external partners to facilitate smooth study progress and timely issue resolution 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 Contribute to the development and writing of clinical study protocols, informed consent forms, and other essential study documents, ensuring scientific rigor and operational feasibility.
Requirements
- Bachelor’s degree in Life Sciences, Healthcare, or a related field with 5+ years related work experience or Masters with 3+ years of related experience or Doctoral degree with 0-2 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
- Oversee site and vendor selection and management activities for clinical trial services, ensuring contracts, scope of work, and performance metrics align with study objectives and Standard Operating Procedures (SOPs).
- Develop and implement comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies to ensure efficient and successful study conduct.
- Establish and maintain robust communication channels with investigators, site staff, internal stakeholders, and external partners to facilitate smooth study progress and timely issue resolution
- 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
- Contribute to the development and writing of clinical study protocols, informed consent forms, and other essential study documents, ensuring scientific rigor and operational feasibility.
Benefits
- health care program
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
