Job Title:
Study Start Up Manager
Location:
Canada (Remote)
Job ID:
2025-118778
Department:
Study Start-Up (ICON Strategic Solutions)
Job Type:
Full-Time, Remote
Application Contact:
Name: Kala Murphy
Message Option: Send a message via job platform
Other Roles: View other roles by Kala
Job Description:
About ICON:
ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence, providing innovative solutions for clinical trials.
Key Responsibilities:
Support the country SSU strategy in collaboration with Study Start-Up Team Lead and global study team.
Ensure SSU timelines and deliverables are met from country allocation until site activation ("Green Light").
Prepare and review IRB/IEC submission packages, Informed Consent Forms, and engage Regulatory Affairs/CTA Hub for Health Authorities submissions.
Coordinate responses to deficiency letters and reportable events, ensuring quality and compliance with regulatory standards.
Ensure TMF documents in study start-up are inspection-ready and maintain financial standards.
Implement efficient processes in line with client strategy.
Oversee local vendor selection and performance as needed.
Lead site selection and ensure sites are ready for "Green Light" for drug release.
Supervise SSU team activities to achieve quality execution according to client standards and local regulations.
Lead local SSU team meetings and contribute to global study team meetings.
Develop country site initiation and patient enrollment plans.
Qualifications & Experience:
Experience: Minimum 5 years in clinical operations, project management, or clinical trial monitoring.
Skills:
Strong understanding of clinical drug development, trial set-up, execution, and monitoring.
Ability to lead in a matrix environment without direct reports.
In-depth knowledge of international drug development standards (GCP/ICH), health authorities (FDA/EMA), and local regulations.
Excellent interpersonal, negotiation, and conflict resolution skills.
Fully bilingual in French and English (spoken and written).
ICON Employee Benefits Include:
Generous annual leave
Health insurance options for you and your family
Competitive retirement savings plans
Global Employee Assistance Programme (TELUS Health)
Life assurance
Country-specific optional benefits, such as:
Childcare vouchers
Bike-to-work schemes
Discounted gym memberships
Subsidized travel passes
Health assessments
More information: ICON Benefits Overview
Diversity & Inclusion Commitment:
ICON is dedicated to providing an inclusive and accessible environment for all candidates, ensuring equal employment opportunities without discrimination.
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