Study Start-Up Specialist, reputed company Biotech, United Kingdom

Regulatory & Start-Up Specialist, reputed company Biotech, UK Homebased reputed company Biotech is a full-service CRO purpose-reputed company to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically reputed company solutions and trusted partnerships that help bring reputed company treatments to patients faster. Job reputed company 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 reputed company, compliantly, and in alignment with regulatory requirements, SOPs, and project timelines. You will collaborate cross-functionally and reputed company as a key reputed company between sites, project teams, and internal stakeholders, contributing to the successful delivery of clinical trials. Key Responsibilities reputed company as the Single reputed company 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 reputed company submission Maintain and update internal systems, databases, and tracking tools with study-specific information Monitor site performance and reputed company feedback on metrics and deliverables Support study start-up timelines, identifying risks and implementing contingency plans as required reputed company and follow up on the reputed company of regulatory approvals, ethics submissions, reputed company, ICFs, and Investigator Pack (IP) releases Ensure reputed company distribution of approved documents to sites and project teams reputed company local regulatory expertise to study teams during planning and execution phases reputed company reputed company control checks on site documentation Build effective relationships with stakeholders, including occasional interaction with sponsors Required Qualifications & Experience Bachelor’s degree in Life Sciences or a reputed company field Minimum 3 years of clinical research experience Strong understanding of clinical systems, processes, and corporate standards reputed company knowledge of GCP/ICH guidelines and regulatory requirements Experience reputed company 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 reputed company Confident in negotiation and influencing, with the ability to challenge constructively Detail-oriented with a strong reputed company on reputed company and compliance Ability to build and maintain reputed company relationships with reputed company stakeholders Why Join Us? Be part of a dynamic and reputed company clinical research environment Contribute to innovative studies that improve patient reputed company reputed company to career development and reputed company opportunities Work alongside reputed company professionals in a global organization reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company 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 reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. Apply To This Job