ICON plc

• Leading the design and development of clinical systems, ensuring alignment with study protocols and operational needs • Collaborating with cross-functional teams to identify opportunities for system enhancements and innovations in clinical trial processes • Overseeing system configuration, integration, and testing to ensure optimal functionality and user experience • Providing strategic guidance on the implementation of new technologies and best practices in clinical system design • Staying current with industry trends and advancements in clinical technology to drive continuous improvement initiatives

• Support the management and execution of clinical trials • Providing administrative support for clinical trials, including managing documentation • Assisting in the preparation and submission of regulatory documents • Collaborating with cross-functional teams to support trial operations • Monitoring and tracking trial progress, including managing site communications • Building and maintaining strong relationships with site staff and other stakeholders

Role Description As a Central Review Coordinator at ICON, you will facilitate the coordination and execution of centralized review activities for clinical trials, contributing to the advancement of innovative treatments and therapies. This is a 100% remote position. What You Will Do: - Take responsibility for clinical research deliverables, applying your skills to ensure quality and efficiency. - Coordinate the scheduling, logistics, and execution of central review activities, including imaging assessments, laboratory analyses, and other centralized evaluations. - Collaborate closely with study teams, clinical sites, and external vendors to ensure timely and accurate collection, transfer, and interpretation of clinical trial data. - Monitor the progress and quality of central review processes, proactively identifying and addressing issues or deviations to ensure adherence to protocol requirements and regulatory standards. - Maintain comprehensive documentation and records of central review activities, ensuring compliance with data management procedures and regulatory requirements. - Provide support and guidance to internal and external stakeholders on central review methodologies, protocols, and best practices. Qualifications - Bachelor's degree in life sciences, computer science, or a related discipline. - Previous experience in clinical research, data management, or study coordination within the pharmaceutical, biotechnology, or CRO industry. - Strong organizational and project management skills with the ability to multitask, prioritize, and manage competing priorities in a fast-paced environment. - Excellent attention to detail and problem-solving abilities, with a commitment to ensuring data accuracy, integrity, and compliance. - Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and build strong relationships with diverse stakeholders. Requirements - Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Benefits - Competitive base salary and performance related incentives. - Health and wellbeing programmes including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programmes and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Benefits may vary depending on role and location. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request.

Role Description As a Senior Clinical Data Science Programmer at ICON, you will develop and implement programming solutions to support the analysis and reporting of clinical trial data. Your experience in clinical data science will be key in delivering high-quality outcomes and mentoring colleagues. - Developing, validating, and maintaining programming solutions for data analysis and reporting in clinical trials. - Collaborating with clinical data scientists and biostatisticians to ensure the integration of programming solutions into the overall data management process. - Overseeing the generation of statistical datasets, tables, listings, and figures to support regulatory submissions and study reports. - Providing guidance on programming best practices, coding standards, and data quality control measures. - Staying updated on advancements in programming languages and data management tools to enhance operational efficiencies. Qualifications - Bachelor's degree in life sciences, computer science, or a related discipline. - Extensive experience in programming for clinical trials, with proficiency in languages such as SAS, R, or Python. - Strong problem-solving skills and the ability to work collaboratively in a fast-paced, cross-functional environment. - Excellent attention to detail and organizational skills, with a commitment to delivering high-quality results. - Strong communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and influence outcomes. Requirements - Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Benefits - Competitive base salary and performance related incentives. - Health and wellbeing programmes including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programmes and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Benefits may vary depending on role and location.

• Preparing, compiling, and submitting regulatory and ethics documentation, including clinical trial applications and ethics committee submissions • Coordinating with internal teams, sponsors, regulatory authorities, and investigative sites to secure required approvals and authorisations for study initiation • Maintaining accurate and inspection-ready records of regulatory submissions, approvals, and essential study documents • Supporting study teams in the development, review, and management of key study documentation, including protocols, informed consent forms, and investigator brochures • Participating in study start-up meetings, providing guidance on regulatory requirements, timelines, and activation strategies • Tracking study start-up milestones and proactively identifying and resolving issues that may impact activation timelines • Ensuring all activities are conducted in accordance with applicable regulations, ICH-GCP guidelines, and company SOPs

Role Description As a Site Specialist II at ICON, you will independently manage a range of site support activities, acting as a key operational contact for sites and contribute to efficient study start-up and maintenance. You will take responsibility for site management and operations deliverables, applying your skills to ensure quality and efficiency. Key responsibilities include: - Coordinating site-level document collection, review, and maintenance, ensuring accuracy and compliance for assigned sites or studies. - Acting as an operational liaison for site staff on documentation, systems, and process-related questions. - Maintaining up-to-date site status, metrics, and key milestones in clinical trial management tools. - Supporting planning and logistics for site meetings, investigator meetings, and monitoring visits. - Identifying opportunities to streamline site workflows and contributing to process improvement initiatives. - Providing guidance to Site Specialist I or junior colleagues, sharing best practices and supporting their development. Qualifications - Bachelor's degree in life sciences, healthcare, business, or a related field, or equivalent clinical research experience. - Relevant experience in site support, clinical administration, or similar roles within CRO, pharma, or healthcare. - Good understanding of clinical trial processes, GCP, and site documentation requirements. - Strong organisational and problem-solving skills, with the ability to manage multiple sites and priorities. - Excellent communication and interpersonal skills, with a proactive, service-focused mindset. - Comfort working independently while collaborating effectively with cross-functional teams. Requirements - Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Benefits - Competitive base salary and performance related incentives. - Health and wellbeing programmes including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programmes and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Benefits may vary depending on role and location. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request.

• Oversee scientific operations workstreams, ensuring deliverables meet quality and timeline expectations. • Lead the design, implementation, and management of clinical trial systems and databases. • Provide expertise in clinical data management and technology solutions to support trial operations. • Collaborate with internal and external stakeholders to ensure system requirements are met and maintained. • Develop and implement data standards and quality control processes to ensure data integrity. • Provide guidance and support to project teams on system-related issues and troubleshooting as needed.

• You will take ownership of clinical trial management deliverables, applying your expertise to complex challenges • Providing administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records • Assisting in the preparation and submission of regulatory documents and ensuring compliance with study protocols and regulatory requirements • Collaborating with cross-functional teams to support trial operations and resolve any issues that arise during the course of the study • Monitoring and tracking trial progress, including managing site communications and ensuring timely delivery of study materials • Building and maintaining strong relationships with site staff and other stakeholders to facilitate smooth trial operations and support overall project success

• Manage clinical trial operations activities, supporting your team and stakeholders to deliver high-quality outcomes across our clinical programmes. • Your focus will be on coordinating clinical trial management delivery, resolving issues, and developing team capability. • Oversee the clinical portion of the budget to ensure efficient resource allocation. • Develop monitoring plans and tools, ensuring effective study oversight. • Train and mentor Clinical Research Associates (CRAs) to optimize their performance. • Drive enrollment and lead study start-up activities, adhering to timelines. • Review trip reports and implement corrective and preventative action plans when necessary. • Foster productive relationships with Sponsors, vendors, and cross-functional teams.

• Leading and coordinating project activities • Ensuring that projects are delivered on time, within budget, and to the highest quality standards • Developing and managing detailed project plans • Leading cross-functional project teams • Monitoring project progress, identifying potential risks and issues • Engaging with stakeholders to manage expectations • Preparing and presenting project reports, status updates, and performance metrics to senior management