Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions)

About the role

iQVIA is seeking an experienced freelance Site Activation Specialist based in the United Kingdom to support clinical trial start-up and site activation activities. The role focuses on UK submission document collection and preparation, site document review, Informed Consent Form (ICF) adaptations and regulatory submission support. It is home-based, starts immediately and lasts approximately 3 to 6 months.

Key responsibilities

• Collect, review and prepare site and regulatory documentation required for UK clinical trial submissions.
• Support the preparation and submission of regulatory packages in line with study requirements and local regulations.
• Perform and coordinate ICF adaptations and associated document updates.
• Review essential site documentation to support Regulatory Green Light readiness.
• Liaise directly with investigative sites to obtain, track and resolve outstanding documentation.
• Ensure the completeness, accuracy and quality of submission packages.
• Maintain study tracking systems, timelines and submission records.
• Monitor site activation progress against project milestones and collaborate with Site Activation Managers, Regulatory Affairs, Project Management and other teams.
• Ensure compliance with ICH-GCP, local UK regulations and study-specific requirements.

Required profile

• Based in the United Kingdom.
• Minimum 2-3 years of experience in Site Activation, Study Start-Up, Regulatory Affairs or Clinical Research.
• Bachelor's degree in Life Sciences or a related field.
• Fluent written and spoken English.

Required skills

• Site document collection, review and submission preparation.
• UK clinical trial regulatory submissions and ICF adaptations.
• Understanding of site activation and study start-up processes.
• Attention to detail and ability to manage multiple priorities and timelines.