Study Delivery Specialist

Job Description

As a Study Delivery Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Role Overview The Study Delivery Specialist (SDS) is responsible for end-to-end operational study delivery, focusing on the completion and maintenance of internal systems/databases/tracking tools and project plans (CSAP) and supporting the study team in study coordination and administrative activities. Key Responsibilities Contribute to the development/review of study documents, vendor management, and cooperation with Local Operating Companies (LOCs) and other internal functions as required. Ensure inspection readiness by overseeing study eTMF completeness. Execute trial management activities as delegated by the Study Delivery Lead (SDL) across all phases and therapy areas, in accordance with standard operating procedures, clinical operational plans, regulatory requirements, and Good Clinical Practice. Work in close partnership with SDL and SDM, providing subject matter expertise across key processes and systems throughout the study lifecycle. Drive continuous improvement initiatives within their remit of expertise, sharing best practices across the business. Set up and maintain systems and tracking tools that ensure quality, consistency, and integration of study data. Support SDL in quality and data oversight to ensure inspection/audit readiness. Manage study team communication, including meetings, info spaces, newsletters, action logs, and communication plans. Coordinate the study budget, managing expenses and tracking updates. Provide input to develop study-specific processes and procedures, adhering to standardization and dissemination of best practices. Depending on experience/expertise, additional responsibilities may include: Preparation and update of study documents and plans. Acting as Local Operating Companies liaison, tracking recruitment progress and compliance. Vendor management and CRO oversight. Contributing to risk management plans. Managing clinical supplies and recruitment materials. Minimum Requirements Graduate or Bachelor level with at least 1+ years of relevant working experience in a pharmaceutical/scientific environment. A scientific background and knowledge of clinical trials (including ICH-GCP) is an asset. Foundation experience in clinical trial delivery, including processes, regulations, operational best practices, and industry standards. Familiarity with key systems used in clinical trial delivery is essential. Strong project management skills, preferably with analytical/financial skills. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family. Various annual leave entitlements A range of health insurance offerings Competitive retirement planning offerings Global Employee Assistance Programme Life assurance Flexible country-specific optional benefits Visit our careers website to read more about the benefits of working at ICON: At ICON, diversity, inclusion & belonging are fundamental to our culture and values. We’re committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Interested in the role, but unsure if you meet all of the requirements? We encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for. #J-18808-Ljbffr