ICON plc

Clinical Research

• Work on multiple trials across cross-therapeutic areas with a start-up focus
• Collaborate with country operations teams to identify, select, and activate clinical trial sites
• Perform Site Qualification Visits to assess site eligibility
• Build relationships with site personnel to facilitate onboarding
• Ensure activities comply with ICH-GCP, local regulations, and internal SOPs
• Coordinate collection of regulatory approvals, contracts, and essential documents
• Serve as the main point of contact for sites, study teams, and external stakeholders during start-up
• Manage investigator contracts, regulatory documents, and site-specific start-up activities
• Provide status updates aligned with project milestones
• Monitor, report, and analyze KPIs related to site selection and start-up timelines
• Identify and address issues that may delay study initiation or affect deliverables
• Maintain accurate documentation for inspection readiness
• Support sites through activation until Green Light status
• Coordinate completion of pre-study requirements including contracts, budgets, and essential documentation
• Assist with audit and inspection preparations

Clinical Research Associate

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct site selection, initiation, routine monitoring, and close-out visits
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain documentation in CTMS and eTMF systems
• Support and track site staff training and compliance records
• Monitor patient safety and ensure timely AE/SAE/PQC reporting
• Support subject recruitment and retention efforts
• Oversee drug accountability and storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and escalate risks or issues to the clinical team
• Assist with site budgets and timely site payments as applicable
• Collaborate with CTAs, LTMs, CTMs, and other cross-functional partners

Clinical Research Associate – Cross Therapeutic Area

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct site selection, initiation, routine monitoring, and close-out visits
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain documentation in CTMS and eTMF systems
• Support site staff training and compliance records
• Monitor patient safety and AE/SAE/PQC reporting
• Support subject recruitment and retention
• Oversee drug accountability and storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and escalate risks or issues
• Assist with site budgets and payments
• Collaborate with CTAs, LTMs, and CTMs

Clinical Research Associate – Cross Therapeutic

Manager

• Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness
• Coordinate development, review, and maintenance of Pharmacovigilance quality standards documents
• Support management of documents through the approval lifecycle within document management systems
• Train Pharmacovigilance and external service provider/vendor staff as requested
• Assist with support and identification of cross functional specific SOPs requiring GPRM training
• Maintain Pharmacovigilance training records to ensure documentation is accurate, up to date, and inspection ready
• Support development and maintenance of Pharmacovigilance training programs and initiatives
• Provide technical expertise on Pharmacovigilance quality standards and training processes
• Identify quality issues, propose solutions, and escalate as appropriate
• Support Pharmacovigilance audit processes and inspections as needed
• Review and provide feedback on Pharmacovigilance documents and templates as requested
• Assist with updates to the Pharmacovigilance System Master File as applicable
• Collaborate with intradepartmental teams, business partners, and external service providers

Manager, Pharmacovigilance SOPs – Training

• Serve as the primary point of communication for assigned trial sites and facilitate internal client teaming to drive issue resolution
• Maintain relationships with critical site stakeholders and provide a voice for sites to client teams
• Contribute to site feasibility, site qualification visits, follow-up, and final site selection
• Coordinate local team activities, recruitment planning, contingency and risk management, budget forecasting, and study-level documentation
• Engage investigators and site staff throughout the trial and communicate status information and issues to stakeholders
• Maintain and update trial management systems and analyze trial progress
• Initiate corrective and preventive actions when trials deviate from plans
• Contribute to site-level recruitment strategy and contingency planning
• Manage country-level vendors, invoices, local study supplies, and vendor selection requests
• Conduct local trial team meetings and facilitate monitoring training
• Prepare and manage country- and site-specific informed consent forms
• Ensure adverse events, serious adverse events, and product quality complaints are reported within required timelines
• Maintain inspection readiness, essential documents, CTMS and eTMF/IF data, and archive records
• Ensure site data quality and timely query resolution
• Support CAPA implementation for audits, inspections, and quality visits
• Ensure accurate finance reporting and proactive country/local budget management
• Organize IEC/HA approvals with the local Start Up team
• Provide systems/process training and contribute to process initiatives
• Complete timely and accurate time reporting
• Manage complex Early Phase trials with internal matrix clinical teams and sites

Senior Clinical Trial Manager

Project Manager

• Manage day-to-day project and programme management activities
• Develop and execute project plans focused on achieving project goals and objectives
• Lead cross-functional teams to ensure successful implementation of project activities
• Collaborate with stakeholders to identify project requirements and define project scope
• Mentor and guide team members, fostering excellence and continuous improvement
• Drive development of project documentation and reports for stakeholders
• Stay abreast of industry trends and emerging technologies to integrate best practices
• Contribute to organizational growth through effective project leadership and strategic planning

Senior Project Manager

Software Engineer

• Develop, implement, and maintain ICON SDTM and ADaM standards libraries from data collection through analysis and submission
• Support sponsors in the development, implementation, maintenance, and governance of clinical data standards content
• Provide internal and external consulting on SDTM compliance, standards implementation, and industry best practices
• Participate in standards governance team meetings and provide standards input as assigned
• Support the development and maintenance of technologies used to implement and manage clinical data standards
• Design and implement standardized programming frameworks for clinical reporting, analysis, and submission deliverables
• Develop and deliver training on CDISC standards-related topics for internal teams and external sponsors
• Provide expert guidance and hands-on support for study-specific R programming activities
• Develop and maintain reusable R packages, functions, utilities, and automation tools, with a specific focus on SDTM processes and deliverables
• Design and develop R Shiny applications to support dashboards and a Data Monitoring Committee initiative
• Perform code reviews and establish best practices to ensure quality, consistency, scalability, and compliance
• Partner with the R Business Solutions Organization to advise on R adoption strategy and roadmap
• Drive the development of scalable templates, workflows, and governance models that support enterprise-wide R adoption
• Contribute to departmental technology strategy and help shape future programming capabilities
• Mentor and coach programmers and statisticians transitioning to R
• Support onboarding and enablement activities for new R users

Principal Clinical Data Standards, R Programmer

Operations

• Take responsibility for scientific operations deliverables, applying skills to ensure quality and efficiency
• Support project managers in the planning, execution, and monitoring of clinical trials
• Assist in the development and maintenance of project timelines, budgets, and resource allocations
• Coordinate with cross-functional teams to ensure timely delivery of project milestones
• Manage study documentation and assist in the preparation of regulatory submissions
• Contribute to the development and implementation of process improvements to enhance operational efficiency

Research Operations Coordinator

• Oversee clinical trial management workstreams, ensuring 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 with cross-functional teams
• Oversee and manage day-to-day clinical trial operations
• Ensure compliance with regulatory standards
• Analyze and interpret clinical trial data, identify trends, and provide insights to optimize study outcomes
• Proactively address challenges and implement effective solutions
• Communicate with internal and external stakeholders to foster partnerships and facilitate smooth trial processes
• Develop the team and manage competing priorities

Clinical Trial Manager

• Manage planning, execution, and delivery of global and local COA/eCOA projects
• Manage local COA/eCOA projects for China with fast turnaround times
• Collaborate with cross-functional teams in and outside China to secure deliverables
• Liaise with local client representatives in China to manage expectations and monitor project progress
• Develop project plans, budgets, and schedules
• Monitor progress to ensure successful project outcomes
• Facilitate communication and stakeholder engagement
• Coordinate team members and clients throughout project execution
• Select and assign translators and reviewers
• Conduct final checks of deliverables and coordinate delivery to clients

Associate Project Manager

Affiliate Manager

• Facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements
• Deliver site start-up and activation work to a high standard
• Assist in preparing and submitting regulatory documents, including clinical trial applications and ethics committee submissions
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Maintain accurate and up-to-date records of regulatory submissions and approvals
• Support study teams in developing study documents, including protocols, informed consent forms, and investigator brochures
• Participate in study start-up meetings and provide input on regulatory requirements and timelines

Site Activation Partner I

• Facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements
• Deliver site start-up and activation work to a high standard
• Assist in preparing and submitting regulatory documents, including clinical trial applications and ethics committee submissions
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Maintain accurate and up-to-date records of regulatory submissions and approvals
• Support study teams in developing protocols, informed consent forms, and investigator brochures
• Participate in study start-up meetings and provide input on regulatory requirements and timelines

Associate

• Lead the initiation of clinical trials, ensuring compliance with regulatory requirements
• Contribute to site start-up and activation activities
• Prepare and submit regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Manage and maintain records of regulatory submissions, approvals, and correspondence
• Provide guidance and support to study teams on regulatory requirements and study start-up best practices
• Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency

Study Start Up Associate II

• Lead the initiation of clinical trials, ensuring compliance with regulatory requirements
• Contribute to site start-up and activation activities
• Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions
• Communicate with regulatory agencies
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Manage accurate records of regulatory submissions, approvals, and correspondence
• Provide guidance and support to study teams on regulatory requirements and study start-up best practices
• Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency

• Facilitate the initiation of clinical trials
• Ensure compliance with regulatory requirements
• Deliver site start-up and activation work to a high standard
• Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Maintain accurate and up-to-date records of regulatory submissions and approvals
• Support study teams in developing protocols, informed consent forms, and investigator brochures
• Participate in study start-up meetings and provide input on regulatory requirements and timelines