Study Start-Up Specialist, IQVIA Biotech, United Kingdom

Regulatory & Start-Up Specialist IQVIA Biotech UK

Homebased

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience we offer agile therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Job Overview

We are seeking a highly motivated Regulatory & Start-Up Specialist to support clinical trial site activation activities across the this role you will play a pivotal part in ensuring studies are initiated efficiently compliantly and in alignment with regulatory requirements SOPs and project timelines.

You will collaborate cross-functionally and act as a key liaison between sites project teams and internal stakeholders contributing to the successful delivery of clinical trials.

Key Responsibilities

• Act as the Single Point of Contact (SPOC) for assigned studies supporting investigative sites Site Activation Managers (SAMs) Project Management and internal teams

• Deliver site start-up and activation activities in compliance with local and international regulations SOPs and work instructions

• Prepare and review regulatory documentation ensuring completeness accuracy and timely submission

• Maintain and update internal systems databases and tracking tools with study-specific information

• Monitor site performance and provide feedback on metrics and deliverables

• Support study start-up timelines identifying risks and implementing contingency plans as required

• Track and follow up on the progress of regulatory approvals ethics submissions contracts ICFs and Investigator Pack (IP) releases

• Ensure timely distribution of approved documents to sites and project teams

• Provide local regulatory expertise to study teams during planning and execution phases

• Perform quality control checks on site documentation

• Build effective relationships with stakeholders including occasional interaction with sponsors

Required Qualifications & Experience

• Bachelors degree in Life Sciences or a related field

• Minimum 3 years of clinical research experience

• Strong understanding of clinical systems processes and corporate standards

• Sound knowledge of GCP/ICH guidelines and regulatory requirements

• Experience within a regulated clinical trial environment and understanding of the drug development lifecycle

Skills & Competencies

• Excellent communication and stakeholder management skills

• Strong organizational and multitasking abilities

• Ability to work independently and prioritize effectively across multiple projects

• Confident in negotiation and influencing with the ability to challenge constructively

• Detail-oriented with a strong focus on quality and compliance

• Ability to build and maintain collaborative relationships with internal and external stakeholders

Why Join Us

• Be part of a dynamic and collaborative clinical research environment

• Contribute to innovative studies that improve patient outcomes

• Access to career development and growth opportunities

• Work alongside experienced professionals in a global organization