Study Start Up Specialist - UK IQVIA Biotech

IQVIA Argentina; Reading; Remote; GBP 45,000 - 55,000; Full time

Job summary

IQVIA is seeking a country-level Site Activation professional for UK-focused responsibilities, including regulatory submissions and activation of clinical sites. This home-based role requires deep knowledge of the UK landscape and strong collaboration with SAMs, PMs and sponsors.

The role emphasizes start-up activities, regulatory document preparation, and maintaining accurate project data while ensuring SOP adherence and timelines.

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 of GCP/ICH and regulatory guidelines.
• Knowledge of applicable regulatory requirements and SOPs.

Responsibilities

• Act as Single Point of Contact (SPOC) for sites, SAM, PM team and others.
• Ensure adherence to SOPs, WIs, quality of deliverables and timelines.
• Perform start up and site activation activities per regulations and SOPs.
• Distribute documents to sites and internal teams.
• Prepare site regulatory documents and review for completeness.
• Maintain internal systems and project tracking tools with site data.
• Review site performance metrics and project timelines.
• Provide local expertise during timeline planning and execution.
• Perform quality control of documents provided by sites.
• Liaise with sponsors on specific initiatives when required.

Skills

GCP/ICH knowledge

Regulatory knowledge

Project coordination

SPOC & communication

Education

Bachelor's degree in life sciences

Job description

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.