Study Start Up Specialist - UK IQVIA Biotech

IQVIA LLC; Greater London; Remote; GBP 35,000 - 55,000; Full time

Job summary

IQVIA is seeking a Country-level Site Activation professional to manage activation tasks for UK sites, working remotely with the SAM and project team. You will ensure regulatory readiness, maintain study documents, and monitor timelines in line with SOPs and ICH/GCP guidelines.

A background in life sciences and 3 years in clinical research are required. This home-based role requires strong knowledge of the UK clinical trial landscape and experience with regulatory submissions, ethics approvals,

Qualifications

• Bachelor’s degree in life sciences or 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 local regulatory requirements, SOPs and company standards.
• Understanding of regulated clinical trial environment and drug development process.

Responsibilities

• Serve as Single Point of Contact (SPOC) in assigned studies for sites, SAM, PM team and other departments.
• Perform start up and site activation activities according to regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Maintain internal systems, databases and tracking tools with project information.
• Review site performance metrics and provide feedback to management.
• Assist in project planning and timeline establishment and monitoring.
• Ensure monitoring measures are in place and implement contingency plans as needed.
• Inform team of completion of regulatory and contractual documents for sites.

Skills

SPOC coordination

Site Activation

GCP/ICH

Regulatory knowledge

Clinical operations

Education

Bachelor's 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.

About IQVIA

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.

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.

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.