ICON plc

Role Description As a Senior Administrative Assistant at ICON, you will bring your expertise to our administrative services function, taking ownership of key deliverables and mentor colleagues across the team. You will take ownership of executive support and administration deliverables, applying your expertise to complex challenges. Key responsibilities include: - Managing complex calendars, scheduling appointments, and coordinating meetings for senior executives and management team members. - Handling confidential and sensitive information with discretion and professionalism. - Drafting and editing correspondence, reports, presentations, and other documents as needed. - Serving as a primary point of contact for internal and external stakeholders, including clients, vendors, and partners. - Coordinating travel arrangements and accommodations for executives and management team members. - Providing administrative support for special projects, events, and initiatives as assigned. Qualifications - Bachelor's degree or equivalent work experience. - Proven experience as an administrative assistant or similar role, supporting senior executives and management in a fast-paced environment. - Excellent organizational and time management skills, with the ability to prioritize tasks and manage multiple deadlines effectively. - Strong communication and interpersonal skills, with the ability to interact professionally with stakeholders at all levels of the organization. - Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook) and other relevant software applications. - Ability to maintain confidentiality, exercise discretion, and handle sensitive information with integrity. - Proactive, detail-oriented, and adaptable, with a positive attitude and willingness to take on new challenges. 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 Senior Administrative Assistant at ICON, you will bring your expertise to our administrative services function, taking ownership of key deliverables and mentor colleagues across the team. You will take ownership of executive support and administration deliverables, applying your expertise to complex challenges. Key responsibilities include: - Managing complex calendars, scheduling appointments, and coordinating meetings for senior executives and management team members. - Handling confidential and sensitive information with discretion and professionalism. - Drafting and editing correspondence, reports, presentations, and other documents as needed. - Serving as a primary point of contact for internal and external stakeholders, including clients, vendors, and partners. - Coordinating travel arrangements and accommodations for executives and management team members. - Providing administrative support for special projects, events, and initiatives as assigned. Qualifications - Bachelor's degree or equivalent work experience. - Proven experience as an administrative assistant or similar role, supporting senior executives and management in a fast-paced environment. - Excellent organizational and time management skills, with the ability to prioritize tasks and manage multiple deadlines effectively. - Strong communication and interpersonal skills, with the ability to interact professionally with stakeholders at all levels of the organization. - Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook) and other relevant software applications. - Ability to maintain confidentiality, exercise discretion, and handle sensitive information with integrity. - Proactive, detail-oriented, and adaptable, with a positive attitude and willingness to take on new challenges. 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.

• Oversee clinical trial management workstreams • Ensure deliverables meet quality and timeline expectations • Collaborate with cross-functional teams to design and implement effective clinical trial enrollment • Develop and implement comprehensive clinical trial protocols • Oversee and manage the day-to-day operations of clinical trials • Ensure compliance with regulatory standards • Analyze and interpret clinical trial data, identifying trends • Provide insights to optimize study outcomes • Proactively address challenges and implement effective solutions • Communicate effectively with internal and external stakeholders

• 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

• Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables • Drive assessment, selection, engagement, management, and oversight of appropriate vendors • Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and sponsor SOPs, for all products and services delivered for their designated studies • Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate • Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project allocation • Preparation of materials for governance and / or financial review cycles and provide expert clinical operational input into protocol development • Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary • Identify and communicate resource gaps for assigned studies • Lead risk management and quality efforts to ensure study compliance and continual inspection readiness • Lead / contribute to ways of working and process improvement initiatives • Encourage others within matrix and line teams to seek alternative perspectives and develop solutions • Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study and collaborate with Oncology aligned staff in global functions to deliver the Clinical Study Report • Work with the Oncology patient councils to develop patient centric documents and address patient burden

• Design and analyse clinical trials, interpreting complex medical data • Manage day-to-day biostatistics activities, supporting your team to deliver quality outcomes • Serve as lead biostatistician for programs of studies, submissions, or on simple to complex individual studies • Oversee statistical activities that support ICON's interactions with clients and regulatory agencies • Review and approve statistical methods sections of study protocols, statistical analysis plans and statistical input to reports • Prepare and approve research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients • Participate in bid defense meetings and make presentations at marketing meetings with prospective clients

Role Description As a Supervisor, Site Payments at ICON, you will manage and oversee the processing and tracking of investigator payments, ensuring timely and accurate payments in compliance with contractual and regulatory requirements. Your focus will be on coordinating pricing and investigator payments delivery, resolving issues, and developing team capability. - Supports Clinical Budget Management (CBM) group in monthly issuance and closeout strategies for program maintenance and close-out for assigned studies - Supports the development, review, and approval of participant travel policies with payment vendor and cross-functional stakeholders for assigned studies - Supports the development, review, and approval of Data Transfer Agreements with payment vendor and Data Management for assigned studies - Supports development of payable budget template in collaboration with the Budget Solutions Team (BST) for assigned studies - Attends study program calls with payment vendor, Clinical Operations Program Lead and other cross-functional team members to set strategies for program startup and amendments as necessary - Management of study milestones and all associated payment activities Qualifications - B.S. or Advanced Degree (or equivalent degree/experience) - Minimum of 5 years relevant work experience including thorough knowledge of site payments - Experience in financial operations, preferably in clinical trials or the pharmaceutical industry - Strong analytical skills with attention to detail and a focus on accuracy - Excellent communication and interpersonal skills to effectively manage relationships with internal teams and external stakeholders - Ability to work independently and manage multiple priorities in a fast-paced environment 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 Site Contracts Negotiator II at ICON, you will independently manage the negotiation and execution of clinical trial agreements and budgets for a range of studies. You will work closely with sites and internal stakeholders to support efficient and compliant study start-up. What You Will Do: - Contribute to contract management activities, taking responsibility for your deliverables and working collaboratively. - Negotiate site contracts and budgets with investigator sites, within defined parameters and playbooks. - Review and adapt contract language to reflect sponsor requirements, local laws, and site feedback. - Manage a portfolio of contracts, monitoring cycle times, and proactively addressing barriers to execution. - Collaborate with legal, finance, and project teams to resolve contractual questions and ensure alignment. - Maintain accurate records of negotiations, approvals, and executed agreements in relevant systems. - Support continuous improvement in contract templates, processes, and guidance, and mentor junior colleagues where appropriate. Qualifications - Bachelor's degree in law, business, life sciences, or a related field, or equivalent experience. - Relevant experience in site contracting, contracts administration, or similar roles within CRO, pharma, or healthcare. - Good understanding of clinical trial agreements and budget negotiation principles. - Strong negotiation, communication, and organizational skills. - Ability to manage multiple contracts and timelines, with attention to detail and quality. - Proactive, solution-focused mindset with a collaborative approach to 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 Manager, Software Development at ICON, you will lead a team of software developers in designing, developing, and implementing innovative software solutions that enhance our clinical operations and research processes. You will manage day-to-day software development and engineering activities, supporting your team to deliver quality outcomes. - Overseeing the software development lifecycle, from requirements gathering and design to coding, testing, and deployment. - Leading and mentoring a team of developers, promoting best practices in software engineering and agile methodologies. - Collaborating with cross-functional teams to define project requirements and deliver high-quality software solutions that meet user needs. - Monitoring project progress and performance, ensuring timely delivery and alignment with organizational goals. - Staying updated on industry trends and technologies to drive continuous improvement and innovation within the development team. Qualifications - Bachelor's degree in computer science, software engineering, or a related field, or equivalent experience. - Extensive experience in software development, with a proven track record in a leadership role. - Strong knowledge of programming languages and frameworks (e.g., Java, C#, .NET, Python) and software development methodologies. - Excellent leadership and communication skills, with the ability to motivate and inspire a diverse team. - A commitment to quality, collaboration, and continuous learning in a fast-paced environment. 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 Due to a number of exciting new projects being awarded to ICON, we are seeking to expand our team and expertise, with the recruitment of a Director of Regulatory Affairs within our US team. We are looking for passionate, resilient, and inspiring individuals to join our Strategic Regulatory Affairs (SRS) team. SRS are a global team of regulatory strategists from pharma, CRO and agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation. We deliver global strategic regulatory consulting, dossier management services and GMP Quality services. As a Director, Regulatory Affairs, you will create a culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs. Representing ICON as a Subject Matter Expert for Regulatory Affairs in the US market, you will proactively communicate objectives and results with clients offering strategic regulatory advice. In this role, you will be responsible for regulatory strategy for a combination of current and prospective clients in the US for drugs and biologics. As a senior member of the SRS team, you will further be responsible for the strategic approach and client interactions necessary to securing new and repeat business, facilitating issue resolution and ensuring project/program timelines/budgets are met. You will also maintain client relationships in the support of future business as the position participates in business development activities. Responsibilities and accountabilities: - Actively anticipate, develop and implement initial or alternative regulatory strategies for contracted clients. - Act as scientific thought leader for ICON. Support initiatives to ensure ICON is at the leading edge of new regulatory developments e.g. DCT, COVID-19, GMO, ATMP development, Cell and Gene therapy etc. - Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise, consulting with other resources within the organization as required. - Manage workflow including prioritizing project objectives, and establishing timeframes for projects with clients and managing client contracts. - Effectively prioritize and complete multiple projects within established timeframes and within budget. - Train, coach, and develop assigned individuals to build overall team expertise. - Develop and implement strategies and regulatory submissions for PIP, OD, SME, MAA and post-licensing activities as applicable. - Function as primary liaison with FDA for designated projects and designated clients. - Conceptualize and draft complete proposals based on a client idea or Request for Proposal (RFP) including Independent development of project plans and scientific content for clients. Achieve a good conversion rate of submitted to won proposals. - Act as scientific thought partner with the client and the project team throughout the project. - May lead a team. Qualifications - Leading FDA pre-IND, End of Phase 2 and Pre NDA/BLA meetings with FDA. - Experience with small molecules, biologics, gene therapy and cell therapies. - Post market support experience. - Excellent verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding. - Planning and organization: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively. - Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation. - Experience in client interaction and/or in a consulting environment is advantageous. - Experience in regulatory writing, meeting packages, dossiers. Requirements - Bachelor’s degree in a relevant discipline, preferably in life sciences, or other healthcare field. - Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological, medical, chemical or engineering field may be beneficial. - Minimum of 12-15 years related experience in Regulatory Affairs setting, in Pharma or CRO, with emphasis on US Regulatory Affairs. - Experience supporting client development activities and people management. 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.