ICON plc

Develop clinical and scientific documents such as reports, protocols, and SOPs, translating laboratory and clinical data accurately while meeting regulatory requirements. | Requires a bachelor's degree in life sciences or a related field, at least three years of relevant medical or scientific writing experience, and strong analytical and scientific-terminology skills. | Technical Medical Writer II - Biomarker Services 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. What You Will Do As a Medical Writer II, you will independently develop high-quality clinical and scientific documents and work closely with scientific, laboratory, clinical, quality, and other cross-functional teams to accurately communicate clinical and laboratory testing data. You will take responsibility for assigned medical writing deliverables, applying your scientific and writing expertise to ensure accuracy, clarity, quality, and timely completion. Key Responsibilities Include: Preparing, writing, editing, and reviewing clinical and scientific documents, including end-of-study reports, laboratory sample testing plans, SOPs, protocols, and other supporting documents. Reviewing, interpreting, and summarizing clinical and laboratory testing data accurately and concisely within required reports, formats, and templates. Ensuring document accuracy, completeness, consistency, and alignment with study requirements, internal SOPs, and applicable regulatory requirements. Collaborating with clinical testing laboratories, scientific subject matter experts, Data Management, Regulatory Affairs, Medical Affairs, Project Management, and Quality Assurance to obtain and clarify information required for document development. Participating in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, data, and deliverables and to provide scientific and editorial input on document content and presentation. Conducting and coordinating quality-control reviews to ensure scientific accuracy, data integrity, formatting consistency, and overall document quality. Managing assigned writing activities and priorities to meet project timelines and deliverables. Providing guidance and support to junior medical writers, as appropriate. Maintaining awareness of relevant scientific developments, clinical research practices, regulatory requirements, and industry guidelines. Your Profile You will bring a strong scientific foundation and relevant medical or scientific writing experience, with the ability to work independently, interpret complex information, and communicate clinical and laboratory data clearly and accurately. Required Qualifications and Experience: Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related scientific, clinical, or regulatory field required; an advanced degree (e.g., MSc, PhD, PharmD, MD) is preferred. A minimum of 3 years of relevant medical or scientific writing experience within the pharmaceutical, biotechnology, CRO, clinical research, or clinical laboratory industry is required. Excellent scientific writing, editing, and proofreading skills, with strong knowledge of scientific and medical terminology and the ability to communicate complex information clearly and concisely. Strong analytical and critical-thinking skills, including the ability to review, interpret, and summarize clinical, scientific, and laboratory data and identify key findings, trends, and inconsistencies. Familiarity with clinical research processes, applicable regulatory requirements, industry guidelines, and scientific documentation standards. Strong attention to detail and a demonstrated commitment to scientific and data accuracy. Ability to work independently while collaborating effectively with scientific, laboratory, clinical, regulatory, quality, and project teams. Ability to manage multiple projects and priorities within a deadline-driven environment. Strong interpersonal and communication skills, including the ability to interact effectively with internal stakeholders and clients. Proficiency with Microsoft Office applications, particularly Word, and familiarity with PDF editing, document publishing, and electronic document management systems. Experience with clinical laboratory testing, biomarker data, or laboratory-generated reports is preferred. Candidates with an advanced scientific degree and substantial relevant scientific writing experience may be considered where their experience demonstrates equivalent scientific, analytical, and writing capabilities relevant to the position. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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. Visit our careers site to read more about the benefits ICON offers. 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 here. Salary Range $83,032.00 - 103,790.00 USD #LI-SB7 #LI-Remote Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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. Visit our careers site to read more about the benefits ICON offers. 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 here. Salary Range $83,032.00-$103,790.00 Are you a current ICON Employee? Please click here to apply

Lead project and programme delivery by managing plans, timelines, budgets, resources, risks, stakeholders, and status reporting. | Requires significant project management and team leadership experience, a bachelor's degree or related education, and strong communication and organizational skills; PMP or PRINCE2 is advantageous. | Project Manager 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. As a Project Manager at ICON, you will be responsible for leading and coordinate project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards. What You Will Do: Your focus will be on coordinating project and programme management delivery, resolving issues, and developing team capability. Key responsibilities include: Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery. Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration. Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track. Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives. Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders. Your Profile: You will have solid project and programme management experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience: Bachelor's degree in project management, business, or a related field is preferred, with significant experience in project management and team leadership. Proven track record of successfully managing projects from inception to completion, with a focus on delivering results within scope, time, and budget constraints. Strong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks. Excellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations. Proficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous. Detail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement. Willingness to travel as required (approximately 30%) Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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. Visit our careers site to read more about the benefits ICON offers. 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 here. Are you a current ICON Employee? Please click here to apply

Lead strategic projects and operational improvement initiatives while supporting proposals, business development, financial reporting, forecasting, and recommendations to leadership. | Requires a bachelor’s degree or equivalent, significant project management experience, strategic initiative and financial analysis experience, advanced Excel, and strong business acumen; clinical research or pharmaceutical experience and PMP certification are preferred. | Project Manager, PM Strategy and Operations 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. Title: Senior Project Manager, PM Strategy and Operations Reports to: Senior Director, Project Management Position Overview The Senior Project Manager, PM Strategy and Operations is a senior individual contributor responsible for leading high-impact internal projects and strategic initiatives across the IMC Project Management organization. This role partners with Project Management leadership and cross-functional stakeholders to drive operational excellence, support commercial and business development activities, provide financial reporting and analysis, and lead integration and process improvement initiatives. The Senior Project Manager serves as an internal subject-matter expert, using strong project management, analytical, and influencing skills to translate business priorities into actionable plans and measurable outcomes. Key Responsibilities Commercial & Business Development Support · Support commercial activities including RFPs, RFIs, proposal development, and budget reviews. · Provide Project Management and operational expertise to help ensure proposed solutions, budgets, assumptions, timelines, and resource requirements are operationally sound. · Partner with Business Development, Finance, and other internal stakeholders to support opportunity planning and proposal development. · Identify operational, financial, resource, and execution risks and recommend appropriate solutions. · Support internal preparation for bid defenses, capability presentations, and other Business Development activities. Financial Reporting & Analysis · Developing and facilitating regular Project Profitability processes and governance. · Support financial reporting, budgeting, forecasting, and analysis across the Project Management organization. · Analyze financial and operational performance to identify trends, variances, risks, and opportunities. · Partner with Finance and Project Management leadership to investigate variances and support development of appropriate action plans. · Evaluate the financial impact of operational decisions and provide actionable insights to support leadership decision-making. · Support continuous improvement of financial reporting, forecasting accuracy, and financial visibility. Strategic Project Management & Operational Excellence · Lead and coordinate complex internal projects and strategic initiatives, establishing clear plans, milestones, deliverables, dependencies, risks, and accountabilities. · Support integration, organizational change, and other cross-functional initiatives impacting Project Management. · Lead and support process improvement activities focused on increasing efficiency, consistency, standardization, and operational effectiveness. · Develop and implement improved workflows, tools, processes, and ways of working in partnership with key stakeholders. · Provide support as requested with clear reporting, analysis, recommendations, and visibility to progress, risks, and outcomes. · Other ad hoc support requests from Sr. Director, Project Management Qualifications Bachelor’s degree in project management, business administration, life sciences, or a related field, or equivalent combination of education and relevant experience. Significant project management experience within a complex, cross-functional organization preferably in clinical trials or pharmaceutical industry. Demonstrated experience leading strategic, operational, integration, or process-improvement initiatives. Experience with financial reporting, budgeting, forecasting, and financial analysis. Experience supporting RFPs, RFIs, proposal development, budget reviews, or Business Development activities preferred. Advanced to expert proficiency in Microsoft Excel, including PivotTables, complex formulas, data validation and analysis, financial and resource tracking, forecasting, and development of project-level and portfolio-level reporting. Strong analytical, organizational, problem-solving, and communication skills. Demonstrated ability to influence and drive results across functions without formal reporting authority. Strong business and financial acumen with the ability to translate data into actionable recommendations. Project management certification, such as PMP, preferred. Key Competencies Strategic project management Financial and business acumen Commercial and Business Development support Data analysis and performance reporting Process improvement and operational excellence Integration and change management Cross-functional leadership and influence Risk management and problem solving Executive-level communication #LI-SB7 #LI-Remote Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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. Visit our careers site to read more about the benefits ICON offers. 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 here. Are you a current ICON Employee? Please click here to apply

Lead reader operations for medical imaging and cardiac safety, overseeing resources, workforce planning, quality, and cross-functional delivery against corporate and regulatory objectives. | Requires a bachelor's degree and 8–10 years of progressive operational leadership, preferably in clinical research or regulated environments, with strong analytical and people-management skills. | Sr Manager, Clinical Operations - IMC - Imaging 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. Overall Job Summary The Senior Manager, Reader Operations, is responsible for the strategic leadership, operational management, and performance of the Reader Operations function. This role oversees the delivery of high-quality medical imaging and cardiac safety services through effective management of reader resources, operational processes, workforce planning, training programs, quality standards, and cross-functional collaboration. The Senior Manager provides vision, leadership, and mentorship to the Reader Operations team while ensuring alignment with corporate objectives, customer expectations, regulatory requirements, and operational excellence standards. The position is accountable for resource utilization, operational efficiency, quality performance, business continuity, technology adoption, employee engagement, and continuous process improvement. Working collaboratively across Project Management, MSA, Readers, Technology, Quality Assurance, Business Development, and Executive Leadership, the Senior Manager ensures operational readiness, successful study execution, client satisfaction, and achievement of departmental goals while maintaining compliance with IMC and ICON policies and procedures. Essential Responsibilities Leadership and People Management Recognize, exemplify, and adhere to ICON's values centered on People, Clients, and Performance. Provide strategic and tactical leadership for the Reader Operations function. Establish and maintain a high-performing, collaborative, and customer-focused team culture. Mentor, coach, and develop Reader Operations staff through performance management, professional development planning, and career growth opportunities. Conduct regular assessments of employee engagement, team effectiveness, and organizational health, implementing action plans as needed. Support workforce planning, recruitment, interviewing, onboarding, succession planning, and retention initiatives. Foster accountability and continuous learning through regular feedback, coaching, and recognition programs. Ensure adequate staffing levels to meet current and future business demands. Reader Workforce Management Oversee reader onboarding, qualification, credentialing, training, and ongoing competency assessment programs. Partner with ICON MSA to ensure optimal reader utilization and assignment strategies. Develop and maintain reader capacity models to support current operations and future growth. Manage reader allocation, workload balancing, and scheduling strategies to maximize efficiency and client responsiveness. Monitor reader productivity, turnaround times, utilization, and quality metrics to ensure operational excellence. Develop contingency plans to address reader availability risks and business continuity requirements. Operational Excellence and Performance Drive operational performance through establishment, monitoring, and reporting of key performance indicators (KPIs), productivity metrics, utilization measures, quality outcomes, and customer service targets. Evaluate operational workflows and implement improvements to enhance quality, efficiency, scalability, and customer experience. Lead departmental process improvement initiatives using data-driven methodologies and best practices. Establish performance benchmarks and service level expectations across Reader Operations. Ensure effective use of operational tools, technologies, and reporting systems. Identify operational risks, develop mitigation plans, and communicate issues to leadership as appropriate. Promote a culture of continuous improvement and operational innovation. Quality and Compliance Ensure compliance with SOPs, regulatory requirements, quality standards, and company policies. Partner with Quality Assurance to support audit readiness, inspections, CAPA activities, and quality improvement initiatives. Monitor operational quality metrics and implement corrective and preventive actions when necessary. Ensure consistency and standardization of operational practices across the Reader Operations organization. Drive a culture of quality, accountability, and regulatory compliance throughout the department. Technology and Innovation Champion technology adoption and workflow optimization initiatives that enhance operational performance and user experience. Partner with Technology, Product, and Business stakeholders to identify opportunities for automation and process efficiencies. Participate in evaluation, implementation, and optimization of operational systems and platforms. Lead change management activities associated with new technologies and business processes. Ensure teams are effectively utilizing available tools and systems to maximize productivity and quality. Client and Cross-Functional Partnership Serve as a senior escalation point for operational, client, reader, and cross-functional issues. Participate in client meetings, governance reviews, audits, and escalation discussions as required. Build strong partnerships with Project Management, MSA, Readers, Technology, Quality Assurance, and other stakeholders. Support business development initiatives by providing operational expertise and resource planning input. Ensure exceptional client service through proactive communication, operational transparency, and delivery excellence. Additional Responsibilities Lead or participate in strategic initiatives, organizational transformation efforts, and special projects. Communicate and implement lessons learned and best practices across the organization. Perform other duties as assigned by senior leadership. Travel possible up to 25%. Education and Experience Requirements Bachelor's degree in Life Sciences, Health Sciences, Healthcare Administration, Business Administration, or a related field required. Advanced degree and/or relevant leadership certifications preferred. Extensive experience in clinical research, medical imaging, healthcare operations, central laboratory operations, or related regulated environments. Minimum of 8-10 years of progressive operational leadership experience, including direct people management responsibilities. Demonstrated success leading large operational teams and managing complex resource planning activities. Proven experience driving operational performance, workforce optimization, process improvement, and organizational change management. Excellent leadership, communication, stakeholder management, and team development skills. Strong analytical and problem-solving capabilities with a data-driven approach to decision-making. Ability to influence and collaborate effectively across all levels of the organization. Experience leading geographically dispersed teams preferred. #LI-SB7 #LI-Remote Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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. Visit our careers site to read more about the benefits ICON offers. 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 here. Are you a current ICON Employee? Please click here to apply

Lead and mentor project managers to ensure successful delivery of imaging projects within budget and time constraints. | Bachelor's degree with advanced degree or PMP preferred, extensive project management experience in clinical research or pharma, and supervisory experience required. | Senior Manager, Project Management - Imaging 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. Job Description Summary Responsible for the overall tactical and strategic direction and management of projects through designated project managers, ensuring consistency with corporate strategy, consistency of process across projects and internal and external customer satisfaction with the projects. Directs and provides day-to-day tactical oversight to their assigned Project Management team. Provides vision, leadership and mentorship to assigned team with respect to performance and career development. Accountable for the overall direction, coordination, implementation, execution, control and completion of all programs/projects, ensuring consistency with company strategy, commitments and goals. Accountable for compliance of the Project Management team with IMC and ICON policies and procedures. Ensure optimal planning, allocation and performance of resources within Project Management. Essential Responsibilities Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance. Recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Maintaining a positive, results-oriented work environment by building partnerships, modeling teamwork and communicating in an open, balanced and objective manner Providing strategic and tactical management to assigned team of Project Managers and Project Assistants Mentoring and managing assigned project management team through establishment of mutually agreed objectives and professional development plans, and by monitoring successful achievement and performance Build and maintain the performance and effectiveness of assigned project management team, including regular checks on team health and identification and resolution (including escalation to the appropriate level) of team performance issues. Ensuring adequate training is provided to employees for all new and updated processes Assessing Training Curriculum and current staff understanding and identify training needs, for new employees and for continuous improvement/development of existing staff Managing project workload and resource forecasts for the group, as well as project assignments Identifying personnel resources for new and existing projects Developing operational metrics for assessment of project performance Serving as the escalation point for project managers in resolution of customer or cross-functional issues that cannot be resolved at the project manager level Ensuring the proper tools are provided to the team and that they are being used effectively; identify/obstacles and make corrective actions/recommendations as necessary Monitoring the efficiencies of current operational processes and identify and/or lead opportunities for improvement Providing senior management with team performance metrics as assigned Lead or participate in strategic planning and risk assessment, by managing the development and delivery of appropriate contingency activities in the context of the budget, time, resources and value targets and in accordance with SOPs. Communicating Best Practice/Lessons Learned Feedback Analyze department and project financial data, identify issues/trends and implement corrective action plans as necessary to ensure profitability. Promoting a proactive, professional culture within the Project Management department and contributing to the group’s success Ensuring the team is compliant with standard procedures and other company policies Leading customer meetings and escalations when required Support staff recruitment, including interviews and supporting hiring process. Other responsibilities as assigned by senior management Travel required up to 25% of the time Education and Experience Requirements: Minimum of a Bachelor’s Degree in life sciences, project management, business administration, or a related field; advanced degree or relevant certifications (e.g., PMP) are preferred. Extensive experience in project management within the clinical research or pharmaceutical industries. Supervisory experience required Strong leadership and organizational skills, with a proven ability to manage multiple projects and priorities effectively. Excellent analytical and problem-solving skills, with a focus on data-driven decision-making. Strong communication and interpersonal skills, capable of engaging and influencing stakeholders at all levels. #LI-Remote #LI-SB7 Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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. Visit our careers site to read more about the benefits ICON offers. 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 here. Are you a current ICON Employee? Please click here to apply

Design, develop, and validate applications supporting clinical trial endpoints and medical imaging workflows while ensuring regulatory compliance. | Bachelor's degree and significant experience in clinical trial technology or medical imaging software development with proficiency in Python or Java and regulated SDLC knowledge. | Senior Software Engineer - Medical Imaging 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. Position Summary The Senior Engineer, Clinical Trial Technology and Medical Imaging Applications is a specialized role within the Production Set-up team. This role is responsible for designing, developing, configuring, validating, and supporting project-specific analysis applications used to support clinical trial endpoints, medical imaging workflows, centralized review, and clinical research operations. The successful candidate must understand how clinical trial protocols, Independent Review Charters, imaging workflows, eCRFs, clinical databases, assessment criteria, sponsor requirements, and operational processes translate into reliable technology solutions that support global study execution. The ideal candidate combines deep expertise in clinical trial technology, medical imaging, software engineering, regulated SDLC practices, quality, regulatory expectations, and operational management. This individual must be able to independently prioritize work, make sound technical decisions based on study-specific needs, reduce technical debt, and ensure applications are fit for purpose for sponsors, sites, readers, adjudicators, data management, and operational teams. What You Will Do Clinical Trial Application Development Design, develop, configure, enhance, and maintain project-specific applications that support clinical trial endpoints, imaging review, operational workflows, and sponsor deliverables. Translate complex clinical, scientific, protocol, operational, and data requirements into technical specifications, application logic, workflows, reports, and user-facing functionality. Develop solutions that support medical imaging, centralized review, endpoint assessment, clinical data capture, study management, reader workflows, adjudication, and operational oversight. Partner with Production Set-up, Product, IT, Data Management, Quality, Clinical Operations, and sponsor-facing teams to ensure applications meet study needs and customer expectations. Support application modernization initiatives, workflow automation, reusable framework development, and reduction of legacy technical debt. Medical Imaging, Central Review, and Independent Review Workflows Develop and support systems used in support of: Blinded Independent Central Review, eligibility review, endpoint review, reader assignment, discrepancy management, adjudication, consensus workflows, and audit trail requirements. Review and interpret clinical trial protocols, imaging manuals, and Independent Review Charters to ensure application design aligns with study-specific endpoint definitions, assessment rules, review workflow, timing expectations, and blinding requirements. Support workflows for image transfer, de-identification, reconciliation, quality control, storage, viewing, measurement, review, archival, and data delivery. Ensure solutions support sponsor, site, reader, adjudicator, medical monitor, and operational management needs across global clinical studies. End-to-End Data Management Consistency Design technology solutions that enable consistent end-to-end data flow across protocol requirements, eCRFs, clinical databases, imaging platforms, assessment applications, operational reports, and sponsor deliverables. Ensure alignment between imaging data, clinical data, assessment results, reader decisions, adjudication outcomes, data exports, and downstream reporting outputs. Identify and mitigate data integrity risks, workflow gaps, traceability issues, duplicate data entry, manual reconciliation burden, and inconsistent endpoint reporting. Partner with Data Management and operational stakeholders to improve data mapping, edit checks, data review workflows, reconciliation processes, and study-specific standards. Support consistent application behavior across sponsor, study, therapeutic area, protocol, and criteria-specific requirements. SDLC, Quality, Validation, and Governance Lead and support all phases of the software development lifecycle, including requirements, solution design, development, testing, validation, UAT, deployment, release management, production support, and continuous improvement. Maintain traceability between protocol requirements, Independent Review Charter requirements, business requirements, functional specifications, technical design, test scripts, validation evidence, and training materials. Develop and maintain SDLC governance materials, technical documentation, SOP and work instruction inputs, training materials, knowledge repositories, and reusable standards. Support risk assessments, impact assessments, root cause analysis, CAPA activities, audit readiness, validation documentation, and regulated change control. Ensure systems and applications align with applicable quality and regulatory expectations, including GxP, GAMP 5, 21 CFR Part 11, ICH-GCP, EU Annex 11, HIPAA, GDPR, and internal quality requirements. Process Improvement and Operational Excellence Lead process improvement initiatives focused on quality, standardization, scalability, operational efficiency, delivery predictability, and reduction of rework. Identify workflow bottlenecks, hidden dependencies, technical debt, single-resource dependencies, knowledge gaps, and application risks that may impact study delivery. Develop reusable development standards, criteria-specific build standards, application templates, testing frameworks, training content, and operational playbooks. Support portfolio-level governance, prioritization, capacity planning, delivery tracking, and leadership reporting for project application development activities. Drive improvements that enable faster study start-up, stronger requirements clarity, consistent delivery, improved data quality, and better sponsor and stakeholder experience. Sponsor, RFI, and Cross-Functional Support Provide technical input for RFIs, sponsor assessments, client audits, demonstrations, solution design discussions, and feasibility reviews. Serve as a senior technical advisor to Production Set-up, Operations, Product, Quality, Data Management, and leadership teams. Communicate complex technical, clinical, imaging, and regulatory concepts clearly to technical and non-technical stakeholders. Mentor engineers and analysts, promote knowledge sharing, and strengthen team capability to reduce single-source dependency. Your Profile Required Qualifications and Experience Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, Clinical Informatics, Information Systems, Life Sciences, or a related discipline. Advanced degree preferred. Significant experience in software engineering, clinical trial technology, medical imaging technology, healthcare technology, or regulated software development environments. Demonstrated experience supporting clinical research, CROs, pharmaceutical or biotechnology organizations, medical imaging providers, imaging core labs, centralized review organizations, or clinical technology vendors. Direct experience supporting centralized imaging review organizations and blinded independent review workflows, including BICR, endpoint adjudication, reader workflows, discrepancy resolution, and imaging review operations. Experience reviewing and translating clinical trial protocols, imaging manuals, Independent Review Charters, data collection requirements, and sponsor requirements into application functionality and technical solutions. Experience supporting systems or applications used for medical imaging, centralized review, endpoint assessment, clinical data capture, data reconciliation, and operational reporting. Strong experience working within regulated SDLC, validation, quality, and change control frameworks. Ability to independently assess competing priorities, make decisions based on study-specific risk and operational need, and deliver high-quality technical solutions with limited oversight. Technical and Domain Skills Programming and Engineering: Python, Java, SQL, REST APIs, JavaScript or related web technologies, database design, application architecture, workflow automation, source control, CI/CD, and release management. Workflow and BPM: BPM or workflow orchestration experience required; Camunda BPM experience strongly preferred. Clinical Trial Systems: EDC, eCRF design, clinical databases, clinical data review systems, CTMS, study management tools, operational reporting, data exports, and clinical data integrations. Medical Imaging Systems: DICOM standards, image transfer workflows, imaging archives, imaging viewers, image QC, reader platforms, annotation and measurement tools, central review platforms, and AI-enabled imaging solutions. ICON-Relevant Technology Context: Experience applicable to Production Set-up and project application build environments, EDC/eCRF/database integrations, workflow automation, criteria-specific application standards, and sponsor-specific study configurations. Validation and Compliance: Computer System Validation, risk-based validation, UAT, traceability matrices, test scripts, validation evidence, audit trails, GxP, GAMP 5, 21 CFR Part 11, ICH-GCP, EU Annex 11, HIPAA, and GDPR. Data and Reporting: Data mapping, data reconciliation, edit checks, endpoint data consistency, data exports, operational dashboards, sponsor reporting, and downstream data delivery standards. Therapeutic Area and Assessment Criteria Experience Working knowledge of imaging and endpoint assessment criteria across therapeutic areas is strongly preferred, including but not limited to: Oncology: RECIST 1.1, iRECIST, irRECIST, mRECIST, Lugano, Cheson, LYRIC, RANO, PCWG3, and volumetric assessments. Cardiac assessments, including quantitative imaging endpoints and study-specific measurement rules. MSK, GI, Neuro, and other specialty imaging workflows and criteria-specific review methodologies. AI-assisted imaging analysis, quantitative imaging, segmentation, volumetric analysis, radiomics, or machine learning enabled imaging workflows in regulated clinical research environments preferred. Preferred Qualifications 8 + years of experience working for or supporting imaging CROs, medical imaging core labs, independent review organizations, eClinical technology providers, or clinical trial technology vendors. Experience with sponsor-facing solution design, technical feasibility assessment, RFI/RFP support, client audits, and regulatory inspection support. Experience creating or maintaining criteria-specific standards, reusable build components, study configuration standards, application design patterns, and operational training materials. Experience leading modernization initiatives, workflow automation, technical debt remediation, and process improvement within clinical trial technology environments. Experience mentoring technical team members and building organizational knowledge management practices. Key Competencies Deep understanding of clinical trial operations, medical imaging workflows, endpoint assessment, and regulated clinical technology delivery. Ability to translate complex clinical, operational, scientific, and regulatory requirements into practical application solutions. Strong independent decision-making, prioritization, analytical thinking, and problem-solving skills. Strong quality mindset with focus on data integrity, traceability, compliance, audit readiness, and customer satisfaction. Ability to influence cross-functional stakeholders and communicate clearly across technical, operational, clinical, quality, and sponsor-facing audiences. Commitment to process improvement, standardization, knowledge sharing, automation, and scalable delivery practices. Role Expectations Act as a senior technical contributor and domain expert for project-specific clinical trial application builds. Ensure solutions are aligned with protocols, Independent Review Charters, assessment criteria, data requirements, sponsor expectations, and operational workflows. Improve consistency across project builds by applying reusable standards, criteria-specific templates, and SDLC governance practices. Support Production Set-up leadership by identifying delivery risks, technical gaps, process inefficiencies, and opportunities for modernization. Help ensure applications support reliable, traceable, end-to-end data management from study setup through review, adjudication, reporting, and delivery. Travel Willingness to travel as required, approximately 15%, based on business, sponsor, audit, training, or project needs. #LI-SB7 #LI-Remote Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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. Visit our careers site to read more about the benefits ICON offers. 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 here. Are you a current ICON Employee? Please click here to apply