Clinical Trial Start-Up Lead: Activation & Submissions

ICON Strategic Solutions; Canada; On-site; CAD 70,000 - 100,000; Full time

Benefits offered by this job

Health and wellbeing programs

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programs and well‑

Learning and development opportunities

Job summary

ICON Strategic Solutions, sponsor-focused CRO, seeks a Study Start-Up Specialist to lead and support clinical trial start-up activities from site activation through ongoing conduct. You will collaborate with investigator sites, study teams, and stakeholders to move studies forward efficiently while ensuring compliance with ICH-GCP, FDA, and local regulations.

This role offers stability, career development, and a collaborative environment with ICON's global expertise.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Clinical research

Site activation

Regulatory submissions

TMF management

Communication skills

Education

Bachelor's degree in Life Sciences

Job description

ICON Strategic Solutions, sponsor-focused CRO, seeks a Study Start-Up Specialist to lead and support clinical trial start-up activities from site activation through ongoing conduct. You will collaborate with investigator sites, study teams, and stakeholders to move studies forward efficiently while ensuring compliance with ICH-GCP, FDA, and local regulations.

This role offers stability, career development, and a collaborative environment with ICON's global expertise.