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

IQVIA Inc; Greater London; Remote; GBP 45.000 - 76.000; Teilzeit

Zusammenfassung

IQVIA Inc 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, ICF adaptations, and regulatory submission support.

You will work with investigative sites and internal study teams to ensure submission packages are complete, compliant, and delivered on time, maintaining study trackers and collaborating

Qualifikationen

• 2-3 years of experience in Site Activation, Study Start-Up, Regulatory Affairs, or Clinical Research.
• Experience with UK regulatory submissions and ICF adaptations.
• Strong attention to detail and ability to manage multiple priorities and timelines.

Aufgaben

• 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

Kenntnisse

Site Activation

Regulatory Affairs

Clinical Research

ICF adaptations

Attention to detail

Project coordination

English communication

Ausbildung

Bachelor's degree in Life Sciences

Jobbeschreibung

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

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