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

• 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

• Leading and coordinate project activities • Developing and managing detailed project plans, including timelines, budgets, and resource allocation • Leading cross-functional project teams and facilitating effective communication • Monitoring project progress and implementing strategies to address challenges • Engaging with stakeholders to manage expectations • Preparing and presenting project reports and performance metrics to senior management

• Country/Study level implementation of Startup and Site Activation Plans • Country/Study level Recruitment Strategy • Responsible to support the development of study level plans • Communication with the local team and internal stakeholders and CRO as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans • Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables • Responsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc. • Project Manager will be able to work independently and exercise their own judgement. • Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close • May manage the study start up process in countries assigned and/or oversee CRO responsible for these activities as applicable • Through the Site Care Partner/Country Trial Manager or CRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements • Provides country level input on Startup and Recruitment milestones • Is accountable for overseeing CRO and/or Project Manager/Site Engagement Liaison for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans) • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. • Ensures compliance to relevant Global and Local, internal and external requirements and regulations. • Ensures timely communication bidirectionally between the global and local study team. • Provides protocol level guidance and support to responsible Local Study Team members as applicable. • Liaise with the team to agree on submission strategy to Health Authorities and Ethic Committees • Identifies country level trends to improve deliverables processes as needed • Ensures audit/Inspection readiness during start-up and conduct • Ensures CRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required