Study Start-up Specialist

Job summary

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.

Job details

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.

What you’ll do

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.

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

Listed skills

• Communication · Preferred
• Problem solving · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• 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

Job areas

• Healthcare
• Science & Research
• Administrative

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