Clinical Study Manager (On-Site US)

About the role

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.

Responsibilities

• Oversight of 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).
• Development and implementation of comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies to ensure efficient and successful study conduct.
• Establishment and maintenance of robust communication channels with investigators, site staff, internal stakeholders, and external partners to facilitate smooth study progress and timely issue resolution.
• Conducting 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.
• Contributing 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.

Qualifications

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

Skills

• Strong organizational and project management skills.
• Excellent communication and interpersonal skills.
• Ability to manage multiple projects simultaneously.
• Knowledge of regulatory guidelines and clinical study protocols.

Benefits

Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.

Pay

Competitive compensation package.

Schedule

Full-time position.