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

Lifelancer Ltd; United States; Remote; USD 85,000 - 159,000; Full time

Job summary

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 primary focus is UK submission document collection and preparation, site document review, ICF adaptations, and regulatory submission support.

The successful candidate will work closely with investigative sites and internal study teams to ensure submission packages are complete, compliant, and delivered on time, while maintaining

Qualifications

• Based in the United Kingdom.
• 2–3 years of experience in Site Activation, Study Start-Up, Regulatory Affairs, or Clinical Research.
• Strong experience with site document collection, review, and submission preparation.
• Experience supporting clinical trial regulatory submissions in the UK.
• Experience performing ICF adaptations.
• Solid understanding of site activation and study start-up processes.
• Fluent English communication skills, both written and verbal.

Responsibilities

• Collect, review, and prepare site and regulatory documentation for UK submissions.
• Support preparation and submission of regulatory packages per study requirements and local regulations.
• Perform and coordinate ICF adaptations and document updates.
• Review essential site documentation to support Regulatory Green Light readiness.
• Liaise with investigative sites to obtain, track, and resolve outstanding documentation.
• Ensure submission packages are complete, accurate, and high quality.
• Maintain study tracking systems, timelines, and submission records.
• Support site activation activities and monitor progress against milestones.
• Collaborate with Site Activation Managers, Regulatory Affairs, Project Management, and other teams.
• Ensure compliance with ICH-GCP and UK regulations.

Skills

Regulatory submissions

Site activation

Clinical research

ICF adaptations

Education

Bachelor's degree in Life Sciences

Tools

ICH-GCP knowledge

Job description

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

Job Location: Manchester, Greater Manchester, United Kingdom

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Location: United Kingdom (Home-Based)

Contract Type: Freelance FTE: 1.0 Start: Immediate Duration: Approximately 3–6 months

About the Role

We are seeking an experienced Freelance Site Activation Specialist based in the United Kingdom to support clinical trial start-up and site activation activities. The primary focus of this role will be UK submission document collection and preparation, site document review, Informed Consent Form (ICF) adaptations, and regulatory submission support . The successful candidate will work closely with investigative sites and internal study teams to ensure submission packages are complete, compliant, and delivered according to project timelines.

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 accordance with study requirements and local regulations
• Perform and coordinate Informed Consent Form (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
• Support site activation activities and monitor progress against project milestones
• Collaborate closely with Site Activation Managers, Regulatory Affairs, Project Management, and other cross-functional teams
• Ensure compliance with ICH-GCP, local UK regulations, and study-specific requirements

Requirements

• Based in the United Kingdom
• Minimum 2–3 years of experience in Site Activation, Study Start-Up, Regulatory Affairs, or Clinical Research
• Strong experience with site document collection, review, and submission preparation
• Experience supporting clinical trial regulatory submissions in the UK
• Experience performing ICF adaptations
• Solid understanding of site activation and study start-up processes
• Strong attention to detail and ability to manage multiple priorities and timelines
• Bachelor's degree in Life Sciences or a related field
• Fluent English communication skills, both written and verbal

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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