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Clinical Study Manager - Core Labs

0-2 years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

Clinical Study Manager - Core Labs (US Remote)


Location:

United States (Remote)


Job ID:

2024-111446


Department:

Clinical Trial Management – ICON Strategic Solutions


Job Type:

Full-Time, Remote


Application Contact:

Name: Jamie Pruitt
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Job Description:

As a Clinical Study Manager at ICON, you will lead and manage global clinical studies in the field of lab diagnostics. You will oversee the planning, execution, and reporting of technical, clinical utility, and clinical performance studies, ensuring compliance with regulatory standards and timelines.


Key Responsibilities:

  • Lead and manage global study teams, with full ownership of study design, timelines, and budget

  • Oversee protocol development, execution, and final reporting

  • Ensure data integrity, database closure, and compliance with regulatory standards

  • Collaborate with internal and external stakeholders, managing vendors and study sites

  • Support regulatory approvals and publication plans


Requirements:

  • Education:

    • Bachelor’s degree in medical technology, chemistry, biology, or related field

  • Experience:

    • Proven experience leading global clinical studies

    • Strong communication, leadership, and problem-solving skills

    • Proficient in Microsoft Office; statistical knowledge a plus

    • Deep understanding of GCP, ICH, and clinical lab standards


Benefits:

  • Competitive salary and annual leave

  • Health insurance options for you and your family

  • Retirement planning with strong savings benefits

  • Global Employee Assistance Program (TELUS Health)

  • Life assurance

  • Country-specific optional benefits (childcare vouchers, gym memberships, etc.)
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Inclusion & Accessibility:

ICON is committed to an inclusive and accessible environment for all candidates, ensuring equal consideration for employment.
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