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Study Start-Up Specialist
Location
United Kingdom
Posted
1 day ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Study Start-Up Specialist
IQVIA
Role Description We are seeking a highly motivated Regulatory & Start-Up Specialist to support clinical trial site activation activities across the UK. In 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 Qualifications - Bachelor’s 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 Benefits - 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
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