Study Start Up Specialist - UK IQVIA Biotech

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

London, United Kingdom

Reading, Berkshire, United Kingdom

Full time

R1571744

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Home Based opportunity requiring in depth knowledge of UK clinical trial landscape and submissions.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.

• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.

• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.

• Distribute completed documents to sites and internal project team members.

• Prepare site regulatory documents, reviewing for completeness and accuracy.

• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.

• Review and provide feedback to management on site performance metrics.

• Review, establish and agree on project planning and project timelines.

• Ensure monitoring measures are in place and implement contingency plan as needed.

• Inform team members of completion of regulatory and contractual documents for individual sites.

• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.

• Perform quality control of documents provided by sites.

• May have direct contact with sponsors on specific initiatives.

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 Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.

Understanding of regulated clinical trial environment and knowledge of drug development process.

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 https://jobs.iqvia.com

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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