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About the Role

Perform country-level Site Activation (SA) activities in accordance with regulations, SOPs, project requirements, and contractual/budgetary guidelines. This role may also include maintenance activities and requires in-depth knowledge of the UK clinical trial landscape and submissions.

Responsibilities

Serve as Single Point of Contact (SPOC) for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments.
Ensure adherence to SOPs, Work Instructions (WIs), quality of 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 timelines.
Ensure monitoring measures are in place and implement contingency plans as needed.
Inform team members of the completion of regulatory and contractual documents for individual sites.
Review, track, and follow the progress, 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 the project team during initial and ongoing project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.

Requirements

Bachelor’s Degree in life sciences or a related field.
3 years of 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 the regulated clinical trial environment and knowledge of the drug development process.

Skills

Site Activation
Clinical Trial Management
Regulatory Submissions
GCP/ICH Guidelines
Document Control
Project Planning
Quality Control

Location

Work Type

Home Based
Full-time

Experience Level

3 years clinical research experience

Education Level

Bachelor’s Degree in life sciences or a related field

About the Company

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

Equal Opportunity

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.