ICON Strategic Solutions

Pharmaceutical Manufacturing · Canada

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Added 7 days ago
IS
CRA 2
ICON Strategic Solutions
Canada
- Full-time
Added 13 days ago
IS
Senior Clinical Research Associate
ICON Strategic Solutions
Canada
- Full-time
Added 13 days ago
IS
Bilingual FR/EN Study Start-up CRA
ICON Strategic Solutions
Canada
- Full-time
Added 13 days ago
IS
Sr Start-up Manager
ICON Strategic Solutions
Burlington, ON
- Full-time
Added 13 days ago
IS
Study Start Up CRA
ICON Strategic Solutions
Canada
- Full-time
Added 20 days ago
IS
Clinical Trial Associate
ICON Strategic Solutions
Burlington, ON
- Full-time
Willingness to report to the Mississauga office 3 days per week
Added 24 days ago
IS
Bilingual Clinical Trial Coordinator - Regulatory/Finance- Montreal
ICON Strategic Solutions
Kirkland, QC
- Full-time
Must have at least 2 years of budget negotiation experience
Added 25 days ago
IS
Site Engagement Lead
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
Sr. Site Management Assoociate
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
Bilingual Senior Site Management Associate (French-speaking)
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
CLINICAL TEAM OPERATIONS LEADERSHIP - BASE
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
Senior Clinical Research Associate
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
Clinical Research Associate
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
Clinical Research Associate
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
Clinical Research Associate
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
Clinical Research Associate
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
Clinical Research Associate
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
Site Start-Up Specialist
ICON Strategic Solutions
Canada
- Full-time
Added 1 month ago
IS
Clinical Study Associate (Hybrid - Mississauga)
ICON Strategic Solutions
Mississauga, ON
- Full-time
Willingness to report to the Mississauga office 3 days per week
Added 1 month ago
IS
Study Start-up Specialist
ICON Strategic Solutions
Canada
- Full-time
Must have experience within a CRO, pharmaceutical company or sponsor environment
Added 1 month ago
IS
Oncology Study Delivery Associate (Hybrid - Mississauga)
ICON Strategic Solutions
Toronto, ON · Greater Toronto Area, Canada
- Full-time
Must have a strong understanding of regulatory documentation
Added 2 months ago
IS
Clinical Trial Manager
ICON Strategic Solutions
Montreal, QC
- Full-time
Added 2 months ago
IS
Investigator Contracts Lead / Site Contracts Lead
ICON Strategic Solutions
Canada
- Full-time
Added 4 months ago
IS
Clinical Trial Coordinator - Finance - Montreal, Canada
ICON Strategic Solutions
Canada
- Full-time
Must have at least 2 years of budget negotiation experience
Added 4 months ago
IS
Clinical Research Associate
ICON Strategic Solutions
Canada
- Full-time

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ICON Strategic Solutions

Study Start-up Specialist

Canada

Full-time

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Job details

Job type: Full-time
Experience: 2+ years of clinical research, site activation, regulatory, or study start-up experience
Posting language: English
Posted: Sep 22, 2026

Original job description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organization, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Study Start-Up Specialist, you will lead and support clinical trial start-up activities, helping investigator sites move efficiently from study start-up through activation and ongoing study conduct.

What You'll Do

✅ Drive site activation and study start-up activities

✅ Coordinate regulatory and ethics submissions (IRB/REB)

✅ Manage essential clinical trial documentation and TMF compliance

✅ Partner with investigator sites, study teams, and key stakeholders

✅ Support protocol amendments and ongoing site maintenance activities

✅ Ensure compliance with ICH-GCP, FDA, and local regulatory requirements

What We're Looking For

2+ years of clinical research, site activation, regulatory, or study start-up experience
Must have experience within a CRO, pharmaceutical company or sponsor environment
Knowledge of ICH-GCP, regulatory submissions, and clinical trial processes
Strong organizational, communication, and problem-solving skills
Bachelor's degree in Life Sciences preferred

Bonus Qualifications

Site Activation Specialist, Study Start-Up Specialist, CTA, Regulatory Coordinator, or Clinical Trial Associate experience
For Canada-based candidates: French/English bilingualism is a plus

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits:

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

Competitive base salary and performance related incentives

Health and wellbeing programs including medical, dental, and vision coverage where applicable

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programs and wellbeing resources

Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Inclusion and Accessibility:

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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More about this job

Responsibilities

The Study Start-up Specialist will lead and support clinical trial activation activities, including regulatory submissions and site maintenance. They will manage essential clinical trial documentation and ensure compliance with ICH-GCP and FDA requirements.

Requirements

Candidates must have at least 2 years of experience in clinical research, site activation, or regulatory affairs within a CRO or pharmaceutical environment. A bachelor's degree in Life Sciences is preferred, along with strong knowledge of clinical trial processes.

Skills

Clinical research
Site activation
Regulatory submissions
Study start-up
ICH-GCP
TMF compliance
IRB/REB coordination
Protocol amendments
Clinical trial documentation
Communication
Problem-solving
Organizational skills

Benefits

Competitive base salary
Performance related incentives
Medical coverage
Dental coverage
Vision coverage
Retirement plans
Pension plans
Life assurance
Disability coverage
Employee assistance programs
Wellbeing resources
Learning and development opportunities

Visa sponsorship

Not detected in the job text

Keywords

Clinical Research
Study Start-up
Site Activation
Regulatory Submissions
ICH-GCP
FDA
TMF
IRB
REB
Clinical Trial
CRO
Pharmaceutical
Biotechnology
Protocol Amendments
Life Sciences
Site Maintenance
Regulatory Compliance

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