Remote UK Study Start-Up Specialist – Site Activation

IQVIA; Reading; Remote; GBP 40,000 - 60,000; Full time

Job summary

IQVIA in Reading, United Kingdom, seeks an experienced Site Activation Specialist to drive country-level site activation tasks. This home-based role requires deep knowledge of the UK clinical trial landscape and regulatory submissions, with responsibility for regulatory documents and project timelines.

You will act as the SPOC for investigative sites and project teams, ensure SOP/WI adherence, and manage start-up activities, document distribution, and quality control.

Qualifications

• Bachelor’s Degree in life sciences or a related field.
• 3 years clinical research experience
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Understanding of regulated clinical trial environment and knowledge of drug development process.

Responsibilities

• Serve as Single Point of Contact (SPOC) for sites and project teams.
• Ensure adherence to SOPs, WIs, deliverables, and timelines.
• Perform site start-up and activation activities per regulations.
• Distribute documents to sites and internal project team members.
• Prepare site regulatory documents for completeness.
• Maintain internal systems and tracking tools with project data.
• Review site performance metrics and provide feedback.
• Plan and agree on project timelines.
• Ensure monitoring measures and contingency plans.
• Inform team of completion of regulatory and contract documents.
• Review, track and follow up the progress of documents and IP releases.
• Provide local expertise to SAMs during project planning.
• Perform quality control of documents from sites.
• May have direct contact with sponsors on initiatives.

Skills

SPOC

Site Activation

Regulatory documentation

Project coordination

GCP/ICH knowledge

Education

Bachelor's Degree in life sciences

Job description

IQVIA in Reading, United Kingdom, seeks an experienced Site Activation Specialist to drive country-level site activation tasks. This home-based role requires deep knowledge of the UK clinical trial landscape and regulatory submissions, with responsibility for regulatory documents and project timelines.

You will act as the SPOC for investigative sites and project teams, ensure SOP/WI adherence, and manage start-up activities, document distribution, and quality control.