ICON plc

• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes • Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards • Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures • Build and manage strong relationships with trial investigators and stakeholders • Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines • Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials • Ensuring protocol compliance, data integrity, and patient safety throughout the trial process • Collaborating with investigators and site staff to facilitate smooth study conduct • Performing data review and resolution of queries to maintain high-quality clinical data • Contributing to the preparation and review of study documentation, including protocols and clinical study reports

• Serve as an effective communication “bridge” between sites, third party vendors and the sponsor • Building and maintaining strong relationships with key stakeholders at clinical trial sites • Monitoring site performance metrics and providing regular updates to study teams on site engagement activities and outcomes • Collaborating with internal teams to develop and implement site engagement strategies tailored to the specific needs of each study and site • Identifying opportunities to improve site engagement and optimize site performance through regular communication and feedback mechanisms • Providing support and guidance to site staff on study protocols, procedures, and regulatory requirements

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials • Ensuring protocol compliance, data integrity, and patient safety throughout the trial process • Collaborating with investigators and site staff to facilitate smooth study conduct • Performing data review and resolution of queries to maintain high-quality clinical data • Contributing to the preparation and review of study documentation, including protocols and clinical study reports

• Coordinate participant scheduling, visit execution, and follow-up across multiple studies • Support recruitment, screening, enrollment, and retention in patients with sleep disorders • Facilitate sleep-specific assessments (e.g., PSG, MWT, actigraphy) and PRO/eCOA completion • Ensure accurate, timely, and ALCOA+-compliant data entry and source documentation • Maintain study files and support ongoing inspection readiness • Assist with query resolution, data reconciliation, and monitoring visit preparation • Track and escalate protocol deviations, eligibility issues, and operational risks • Coordinate cross-functional communication between site, CRO and sponsor teams • Support IP handling and site logistics, as applicable • Assist with data entry into EDC as needed

• The LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level • Managing the consistency of Local Trial Management duties and processes • Serve as the country-level single point of contact on the study for internal partners • Manage and oversee Central IRB and other local vendors, including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable • Execution of local milestones from feasibility through study close out • Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM) • Inspection Readiness and AQR at the country level • Close collaboration with the assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training, where necessary • Efficient communication with the Clinical Trial Managers, Clinical Operations and the Global Trial Leader to oversee trial excellence • Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables • Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership

Role Description As a Senior Clinical Trial Manager at ICON, you will 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. - Budget Oversight: Oversee the clinical portion of the budget to ensure efficient resource allocation. - Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight. - Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance. - Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines. - Improving Study Integrity: Review trip reports and implement corrective and preventative action plans when necessary. - Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams. Qualifications - A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization. - Bachelor's degree in health, life sciences, or other relevant fields of study. - At least 10+ years of relevant experience in clinical trial management. - Preferred: 2+ years of monitoring experience. - Experience in managing complex or global trials is advantageous. - Preferred: Experience in managing all trial components from start-up to database lock. - Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives. - Willingness to travel as required (approximately 25%). 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. Company Description ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Role Description As a CDC II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. Your role will involve delivering clinical data management work to a high standard, working closely with your team and stakeholders. - Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures. - Manage clinical and third-party data reconciliation based on edit specifications and data review plans. - Tracks and communicates status of study and task metrics to clinical data scientist, project team, and functional management. - Address data related questions and recommend potential solutions. - Identify root cause to systematically resolve data issues. Qualifications - Bachelor's degree in a relevant field, such as Life Sciences or Healthcare. - Intermediate knowledge of clinical data management within the pharmaceutical or biotechnology industry. - Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar). - Strong attention to detail and the ability to work effectively in a fast-paced environment. - Excellent communication skills and the ability to collaborate with cross-functional teams. - Knowledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus. 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.

Role Description As a CDC II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. Your role will involve delivering clinical data management work to a high standard, working closely with your team and stakeholders. - Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures. - Manage clinical and third-party data reconciliation based on edit specifications and data review plans. - Tracks and communicates status of study and task metrics to clinical data scientist, project team, and functional management. - Address data related questions and recommend potential solutions. - Identify root cause to systematically resolve data issues. Qualifications - Bachelor's degree in a relevant field, such as Life Sciences or Healthcare. - Intermediate knowledge of clinical data management within the pharmaceutical or biotechnology industry. - Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar). - Strong attention to detail and the ability to work effectively in a fast-paced environment. - Excellent communication skills and the ability to collaborate with cross-functional teams. - Knowledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus. 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.

Role Description As the Vice President, Site Activation Project Management and Global Regulatory Oversight at ICON, you will provide strategic and operational leadership for our global study start-up organization, ensuring the timely, compliant, and efficient initiation of clinical trials across diverse customer portfolios. Your leadership will shape global site activation and regulatory strategy, build organizational capability, and ensure delivery excellence at scale. Key Responsibilities: - Developing and implementing comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry requirements. - Leading a global organization of site activation and regulatory professionals to drive efficiency, collaboration, accountability, and high-quality project outcomes. - Overseeing the harmonized FSA operating model supporting both large pharma and biotech customers, ensuring consistency, scalability, and operational excellence across client portfolios. - Serving as the executive leader for sponsor-facing study start-up delivery, with FSA teams acting as the primary client interface coordinating execution across Site Selection, Regulatory Affairs, Contracts, Site Activation, and other key functional areas. - Providing leadership and oversight of the Global Regulatory Partner team, ensuring strategic regulatory guidance, study-level regulatory oversight, and effective management of global submission activities. - Partnering closely with Clinical Operations, Project Management, Business Development, and other cross-functional leaders to proactively identify and resolve study start-up challenges and risks. - Establishing, monitoring, and improving key performance indicators, cycle times, quality measures, and operational metrics to drive continuous improvement and predictable delivery. - Building and maintaining trusted relationships with sponsors and external stakeholders, serving as an executive escalation point and strategic advisor throughout study start-up and activation activities. - Driving organizational transformation, process harmonization, and innovation to enhance the customer experience and improve study start-up performance globally. - Fostering a culture of collaboration, inclusion, accountability, and talent development across geographically distributed teams. Qualifications - Bachelor's degree in a scientific, healthcare, life sciences, or related field; advanced degree preferred. - Extensive experience in clinical study start-up, site activation, and regulatory operations within a Contract Research Organization (CRO) environment, with a proven track record of leading successful study launches across global programs. - Significant leadership experience managing large, geographically dispersed teams and developing high-performing leaders. - Demonstrated success overseeing sponsor-facing delivery organizations and building strong strategic partnerships with pharmaceutical and biotechnology clients. - Deep understanding of global regulatory requirements, submission processes, and study activation activities across multiple regions. - Proven ability to lead cross-functional organizations and influence outcomes across Site Selection, Regulatory Affairs, Contracts, Activation, Clinical Operations, and Project Management functions. - Strong strategic thinking, operational excellence, and change leadership capabilities with experience driving process improvement and organizational transformation. - Exceptional communication, executive presence, and relationship-management skills, with the ability to effectively engage internal and external stakeholders at all levels. - Commitment to fostering diversity, inclusion, collaboration, and continuous learning within teams and across the organization. - Prefer candidates who live in the US, but candidates in Europe will also be considered. - Able to travel domestically and internationally up to 25%. 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. Company Description ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.