• Provide leadership and direction to clinical site management team members from study start through to closure • Serve as Site Management primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to: 1. Primary Sponsor contact 2. Investigator and Bid Defense Meetings 3. Internal and External study team calls 4. Project-specific Audits / Inspections • Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities • Oversee compliance to the Clinical Monitoring Plan, including site visits, outstanding trip reports and visit follow up letters

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Clinical Operations Department does at Worldwide Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve. These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. All CROs will promise you growth, opportunity and maybe even a challenge. But we offer more than that. We offer an uncommon experience – one you can’t get anywhere else, with a team unlike anyone else. At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you daily - committed to advancing science and moving mountains for our customers. What you will do - Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects, which are predominantly registries and other types of non-interventional / observational studies - Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded - Conduct study initiation visits (SIVs) - While most of the site management efforts will be performed remotely, will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirement What you will bring to the role - Excellent interpersonal, oral, and written communication skills in English - Superior organizational skills with attention to details - Ability to work with little or no supervision - Proficiency in Microsoft Office, CTMS and EDC Systems Your experience - 5+ years of experience as a Clinical Research Associate - 4-year university degree or RN/BSN in Nursing - Willingness to travel required We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

• In this vital role, the Clinical Scientist Associate Director will support the execution of cardiovascular trials by translating scientific and clinical strategy into high-quality study delivery across global, complex, late-stage clinical trials. • The Clinical Scientist serves as a key clinical development team member, providing hands-on oversight of protocol execution, medical data review, endpoint quality, and cross-functional issue resolution to enable timely, decision-ready data. • This role works collaboratively across clinical, medical, operational, data management, safety, and regulatory teams to ensure studies are conducted in alignment with protocol intent, study timelines, regulatory expectations, and Amgen quality standards. • Serve as a clinical and scientific subject-matter expert for cardiovascular trials, with deep understanding of cardiovascular disease, endpoint strategy, protocol execution, and data integrity. • Contribute to medical monitoring activities and support ongoing review of subject-level and aggregate clinical data to identify safety signals, endpoint trends, protocol deviations, and emerging operational or scientific risks. • Present information internally and externally, anticipating and actively managing issues across a broad spectrum of cross-functional stakeholders, governance bodies, and external partners. • Provide guidance and oversight in the identification and management of collaborators, consultants, adjudication vendors, and/or Clinical Research Organizations (CROs) to support successful trial delivery. • Work cross-functionally to translate clinical strategy into study concept documents, protocols, endpoint definitions, charters, data review plans, and other key trial documents required for CV trial execution. • Ensure the scientific and operational integrity of protocols and clinical plans, including delivery of final protocol content and governance approvals for large, global, event-driven studies. • Provide clinical input into study startup, trial conduct, enrollment oversight, endpoint ascertainment, adjudication readiness, data review, and interpretation of results. • Review and analyze clinical trial data to ensure accuracy, completeness, consistency, and adherence to protocol, endpoint definitions, and regulatory requirements, with strong focus on MACE and other cardiovascular outcome measures where applicable. • Lead thorough data quality assessments in the context of a data monitoring and review plan to maintain high standards of endpoint reliability, safety oversight, and inspection readiness throughout the trial lifecycle.

Clinical Trial Manager, Biotech - Remote, US ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development As a 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. What You Will Do: You will manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes. Key responsibilities include: - 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. Your Profile: You will have solid clinical trial management experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience: - University degree in medicine, science, or equivalent combination of education & experience - Demonstrated ability to drive the clinical deliverables of a study - Subject matter expertise in the designated therapeutic area - Prior monitoring experience is preferred - Willingness to travel as required (approximately 25%) 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. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply