Site Activation Manager

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, 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.

The Site Activation Manager is a sponsor-dedicated role delivered through a partnership with ICON and responsible for United States study start-up and amendment activities. The role builds strong relationships with investigative sites, drives essential document collection and quality review, supports country and site ICF development and negotiation, ensures IRB submission readiness and approval follow-up, manages amendment implementation, and partners cross-functionally to achieve timely site activation and amendment implementation.

What You Will Do:

Your focus will be on coordinating site start-up and activation delivery, resolving issues, and developing team capability.

Key responsibilities include:

• Build strong working relationships with investigative sites and support a positive sponsor-site experience throughout start-up.
• Collect, review, QC, and file essential documents required for submission and activation.
• Review and negotiate ICF changes with sites and stakeholders; manage translations, checklists, filing, and amendment updates as required.
• Ensure IRB submissions are made and approval documentation is complete and activation-ready.
• Support regulatory and clinical trial start-up activities across the US, including coordination of submission, approval, and study activation workflows.
• Collaborate with sites and internal stakeholders to set and achieve Regulatory Greenlight (RGL) goals that support timely site activation.
• Escalate risks, manage timelines, and maintain accurate documentation and tracking in systems such as CTMS and the eTMF.
• Manage protocol amendments and related submissions, approvals, site communications, and implementation activities.

Your Profile:

You will have solid site start-up and activation experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• Clinical trial start-up experience in a site-facing or dedicated site role.
• Solid understanding of ICH GCP, applicable ethics committee requirements (IRB), and regulatory submission processes across the United States.
• Experience with essential document collection, QC, and filing.
• Experience with ICF review, negotiation, and amendment management.
• Strong cross-functional collaboration and stakeholder management skills within a sponsor-partner operating model involving ICON.
• Excellent written and spoken English, with strong organization, judgment, and stakeholder-management skills.
• Experience with clinical trial management, electronic trial master file, or comparable research systems.
• Ability to work independently across North American time zones.

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 programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

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.

Are you a current ICON Employee? Please click here to apply