ICON plc

Clinical Research

• Oversee the clinical portion of the budget to ensure efficient resource allocation.
• Develop monitoring plans and tools, ensuring effective study oversight.
• Train and mentor Clinical Research Associates (CRAs) to optimize their performance.
• Drive enrollment and lead study start-up activities, adhering to timelines.
• Review trip reports and implement corrective and preventative action plans when necessary.
• Foster productive relationships with Sponsors, vendors, and cross-functional teams.
• Identify and mitigate risks.
• Provide comprehensive reporting on all clinical activities.

Senior Clinical Trial Manager

Recruitment

• Encourage patients to participate in clinical research studies through conducting phone screens
• Review patients’ basic medical information to determine eligibility
• Discuss research opportunities with patients
• Maintain the patient database and report recruitment outcomes
• Screen potential study participants according to protocol inclusion and exclusion criteria
• Review, enter, and edit patient information into clinical trial management software
• Book patients into site schedulers and ensure entries are accurate and up to date
• Read and understand the purpose and inclusion/exclusion criteria for each protocol
• Respond to all leads within 24 hours
• Identify appropriate study opportunities for interested volunteers based on knowledge of clinical trials and neighboring locations
• Problem solve and create contingency plans to optimize enrollment
• Communicate the importance of research participation to volunteers
• Provide an exceptional patient experience through positive rapport and consistent follow-up
• Meet personal and team targets
• Maintain strict confidentiality in electronic, written, and verbal forms
• Deliver high-quality, accurate work and ensure administration is filed accordingly

Patient Recruitment Associate I

Compliance

• Design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies
• Oversee quality assurance and compliance workstreams, ensuring deliverables meet quality and timeline expectations
• Develop and implement comprehensive quality management systems and processes
• Lead internal and external audits and inspections, including planning, execution, and follow-up activities
• Address audit and inspection findings and ensure timely resolution
• Conduct regular quality reviews of clinical trial documentation, protocols, and study reports
• Identify areas for improvement and implement corrective actions
• Provide leadership and guidance to the clinical quality compliance team, including training, mentoring, and performance management
• Collaborate with cross-functional teams to assess quality risks, develop risk mitigation strategies, and drive continuous improvement initiatives

Clinical Quality Compliance Lead

• Implement and monitor clinical trials to ensure sponsor and investigator obligations are met and comply with local regulatory requirements and ICH GCP guidelines
• Assess potential investigative sites, initiate trials, instruct site personnel, and close trials at investigative sites
• Perform site startup activities, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget and contract negotiations
• Review and verify clinical trial data collected onsite or remotely
• Provide regular site status information and update trial management tools
• Complete monitoring activity documents according to sponsor SOPs
• Work with clinical team members to resolve trial and clinical issues
• Escalate site and trial issues according to sponsor SOPs
• Perform essential document site file reconciliation
• Perform source document verification and query resolution
• Assess investigational product accountability, dispensation, and compliance
• Verify serious adverse event reporting according to trial specifications and ICH GCP guidelines
• Communicate with investigative sites and update tracking systems
• Ensure required training is completed and documented
• Function with little oversight at the senior level
• Serve as a subject matter expert for clinical operations monitoring activities
• Provide leadership to assigned clinical operations projects
• Serve as observation and performance visit leader
• Interact with other functional areas to resolve site issues and facilitate trial timelines

Senior Clinical Research Associate

Business Operations

• Create, generate, and manage purchase orders in Ariba/SAP following full contract execution
• Translate contractual payment terms, milestones, and fee structures into accurate purchase order structures
• Review executed agreements for financial setup, funding allocations, payment schedules, and budget tracking
• Process change orders, PO amendments, closures, and funding adjustments
• Partner with R&D, Finance, and Strategic Sourcing to resolve system or budget discrepancies
• Monitor PO lifecycle activities, including invoice matching, goods receipt confirmations, accrual support, and PO reconciliation
• Ensure compliance with financial controls, delegation of authority policies, and procurement procedures
• Serve as system subject matter expert for Ariba/SAP purchase order workflows
• Train business partners on purchase requisition and PO processes
• Facilitate operational status meetings related to PO issuance, budget tracking, and financial metrics
• Generate reports and dashboards for PO cycle times, open commitments, spend against budget, and operational KPIs
• Support month-end and year-end close activities, including accrual validation and financial reconciliation
• Identify and implement process improvements
• Support audit requests and compliance reviews related to procurement and purchase order activities

Manager, R&D Business Operations

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

Clinical Trial Manager

General

• Provide vendor oversight for adherence to budget, timelines, and organizational objectives of individual protocols/programs
• Develop and maintain vendor and site relationships throughout all phases of the trial
• Maintain in-depth understanding of study protocols and related procedures
• Share best practices, make recommendations for continuous improvement, and provide training
• Coordinate and manage tasks to achieve site readiness, including study materials and drug shipping/receipt approval
• Review monitoring reports from CROs and associated deliverables for sponsor oversight
• Review CRO eTMF/TMF for standards and regulatory compliance
• Revise vendor scope of service agreements, budgets, plans, and timelines
• Support study financial management, including review and approval of site and vendor invoices
• Support risk management and audit/inspection activities
• Maintain clinical trial registry entries and updates
• Mentor and guide junior team members or cross-functional colleagues

Clinical Study Lead, CTM II

Software Engineer

• Develop, validate, and maintain complex statistical programs for data manipulation, analysis, and reporting in clinical trials
• Collaborate with biostatisticians and cross-functional teams to interpret study requirements and implement statistical analyses accurately
• Prepare and review statistical analysis plans, programming specifications, and derived datasets to meet regulatory standards
• Ensure data integrity and compliance with industry regulations, including ICH/GCP guidelines
• Mentor junior programmers and assist in training team members on programming techniques and best practices
• Take responsibility for statistical programming deliverables in a sponsor-dedicated model

Statistical Programmer II

Clinical Data Coordinator

• Create and maintain detailed data management plans and documentation, ensuring compliance with industry standards and regulatory requirements
• Identify and resolve data discrepancies and issues to streamline data flow and enhance data quality throughout the study lifecycle
• Collaborate with clinical operations and biostatistics teams to develop and execute study-specific data management strategies
• Perform project activities such as filing and archiving study documentation and dispatching queries to investigator sites
• Mentor junior data coordinators on data reconciliation, coding, and cleaning procedures
• Lead clinical research tasks requiring technical depth, with a focus on quality and continuous improvement
• Ensure study timelines are met

Senior Clinical Data Coordinator

Scientist

• Lead COA study projects from end to end and ensure development and establishment of fitness-for-purpose COAs, including PROs, ClinROs, PerfOs, and ObsROs
• Manage COA research projects and engage with external third parties to ensure timely project execution with quality and compliance
• Support development of disease-state and product-specific COA strategies with functional and cross-functional teams
• Execute COA strategies with functional and cross-functional teams
• Support integration of COA into early clinical development plans
• Draft regulatory documents under direction of the lead COA scientist
• Design and execute research to inform COA strategy development
• Develop and execute qualitative and psychometric analysis strategies
• Support clinical trial development, including protocols, statistical analysis plans, study reports, briefing books, and related documents
• Identify evidence gaps needed to support fit-for-purpose use of COAs
• Design and execute research to develop or modify COA instruments
• Consult on COA regulatory strategy
• Develop publications for peer-reviewed journals and scientific meetings
• Package scientific materials for patients and caregivers for dissemination and disclosure
• Partner with project management teams to deliver planned work
• Communicate project status transparently to team members
• Ensure appropriate measures and metrics are in place
• Monitor the external environment and define future needs and priorities

Senior COA Scientist

Manager

• Manage day-to-day site start-up and activation activities
• Manage and oversee the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation
• Lead a team of study start-up professionals, providing guidance, mentorship, and support
• Collaborate with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines
• Monitor study start-up metrics, timelines, and budgets
• Identify risks and challenges in the start-up process and implement mitigation strategies
• Drive continuous improvement initiatives to optimize study start-up processes and efficiency

Manager, Study Start Up

Project Manager

• Partner with assigned HCI Leads to build and maintain integrated project plans, timelines, milestones, and budgets across concurrent HCIs
• Translate HCI strategy into structured workplans and track deliverables, dependencies, risks, opportunities, and issues
• Maintain regular touchpoints with external collaborators during project ramp-up and tapering
• Coordinate cross-functional and cross-BU logistics across Medical Affairs, E&C, Legal, and external partners
• Support information requests, work orders, scope changes, payments, budget tracking and reconciliation, and milestone monitoring
• Monitor spend against plan, flag variances, and identify compliance issues related to funding regulations
• Compile, organize, and quality-check data and materials for HCI measurement and reporting
• Prepare and synthesize materials for external meetings, internal leadership discussions, Steering Committees, and governance forums
• Capture decisions and action items and drive follow-through
• Help maintain HCI technology and ecosystem tools, including trackers, dashboards, and collaboration platforms
• Lead landscape analyses of new disease states, HCI focus areas, and approaches
• Identify opportunities to standardize or streamline recurring operational processes across the HCI portfolio
• Perform additional operational tasks as required by portfolio demands and HCI Lead needs

Healthcare Improvement Project Manager

• Develop and execute project plans, focusing 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 a culture of excellence and continuous improvement
• Drive development of project documentation and reports for clear, actionable presentation to stakeholders
• Stay abreast of industry trends and emerging technologies to integrate best practices into project management strategies
• Contribute to organizational growth through effective project leadership and strategic planning

Senior Project Manager, Cardio-Metabolic

Associate

• Lead site start-up and activation tasks requiring technical depth, with a focus on quality and continuous improvement
• Conduct feasibility assessments and site identification
• Negotiate site contracts and perform other critical study start-up activities
• Provide expertise to Study Start Up team leads and project teams
• Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies
• Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms
• Support the Study Start Up Team Lead in developing and executing the plan for country and site distribution

Senior Study Start Up Associate

• Oversee day-to-day site management activities, ensuring clinical trial sites comply with study protocols, regulatory requirements, and timelines
• Collaborate with site staff and cross-functional teams to resolve issues, monitor progress, and ensure timely data collection and reporting
• Assist with site initiation, monitoring visits, and close-out activities
• Provide guidance and mentorship to junior site management staff
• Prepare and maintain site management documentation, including site reports, communications, and site performance updates
• Lead clinical research tasks requiring technical depth, with a focus on quality and continuous improvement