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Study Start Up Project Manager

5-7 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:

Study Start Up Project Manager


Location:

United States (Remote)


Job ID:

2025-118485


Department:

Study Start Up
(ICON Strategic Solutions)


Job Type:

Full-Time, Remote


Application Contact:

Name: Brendan Hoey
Message Option: Send a message via job platform
Other Roles: [View other roles by Brendan]

 

Job Description (Archived):

About ICON:
ICON plc is a leading global healthcare intelligence and clinical research organization, committed to excellence, inclusion, and shaping the future of clinical development.


Key Responsibilities:

  • Manage and deliver site activations for clinical studies, particularly those with high operational complexity.

  • Coordinate study-level and country-specific tasks including vendor setup, regulatory submissions, and investigational product supply to meet activation goals.

  • Lead start-up meetings to align activities with trial optimization plans and milestone delivery (e.g., FPFV, site activation targets).

  • Collaborate with country-level roles to explore acceleration opportunities and address activation challenges.

  • Maintain oversight of site activation timelines from initial package dispatch to site activation completion.

  • Act as escalation point for site activation issues, ensuring follow-through and resolution.

  • Contribute to risk assessments and mitigation strategies to optimize site activation performance.


Candidate Profile:

  • Education:

    • BS/BA with minimum 7 years relevant experience

    • MS/PhD with minimum 5 years relevant experience

    • Preferred background in science or technical fields

  • Experience:

    • Extensive global study start-up management (North America, Asia, Europe) across multiple therapeutic areas.

    • Strong understanding of clinical trial methodology, GCP, and regulatory operations.

  • Skills:

    • Fluency in English

    • Project management leadership

    • Cross-functional collaboration

    • Timeline planning and issue resolution


Benefits Offered by ICON:

  • Varied annual leave entitlements

  • Comprehensive health insurance plans

  • Competitive retirement savings options

  • 24/7 Global Employee Assistance Programme (TELUS Health)

  • Life assurance

  • Optional benefits: gym memberships, travel subsidies, bike schemes, childcare vouchers, and more

🔗 More about ICON’s benefits


Diversity & Accessibility:

ICON is an equal opportunity employer committed to diversity, inclusion, and a discrimination-free work environment. Reasonable accommodations are available for applicants with medical conditions or disabilities.