ICON plc

Nurse

• Conduct comprehensive reviews of clinical trial protocols, patient records, and medical documentation to ensure compliance with study protocols and regulatory requirements
• Collaborate with clinical teams to assess patient eligibility, adverse events, and protocol deviations, providing clinical insights and recommendations as needed
• Assist in developing and implementing nursing review processes and procedures to optimize data quality and integrity
• Participate in data collection and analysis activities, contributing to the interpretation and reporting of clinical trial results
• Maintain accurate and detailed documentation of nursing review activities and findings, adhering to company and regulatory guidelines
• Design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies

Clinical Nurse Reviewer – Independent DMC and Endpoint Adjudication

Data Scientist

• Develop and oversee the timeliness of clinical data science activities during the life cycle of studies as they relate to data review and data delivery milestones
• Negotiate timelines and key deliverables with clients, external customers, vendors, and departments
• Participate in sponsor and/or third-party audits
• Forecast budget, hours, and resourcing for clinical data review activities
• Perform analytic review focusing on errors that matter or meaningfully impact subject safety or final analysis interpretation
• Work and collaborate with cross-functional and global groups
• Provide input into clinical system development and clinical risk management activities
• Develop planning documents related to data review, data analytics, and data deliverables
• Establish approaches and lead resources to achieve operational and strategic plans
• Track and communicate issues affecting project target dates, scope, or budget, escalating potential problems effectively and promptly
• Apply existing procedures and analyze information and standard practices to make judgment calls
• Travel approximately 15% domestically and/or internationally

Clinical Data Science Lead

Associate

• Lead the initiation of clinical trials
• Contribute to site start-up and activation activities
• 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 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

Medical Billing and Coding

• Ensure accurate and consistent coding of medical data for clinical trials
• Take ownership of scientific operations deliverables, applying expertise to complex challenges
• Independently review data coded by third parties to ensure consistent coding
• Oversee outsourced CRO work through medical coding review and synonym dictionary review
• Review and maintain guidance and training documentation for coding guidelines in accordance with ICH guidelines and dictionary definitions
• Support other departments concerning dictionary use and coding quality
• Collaborate on creation and maintenance of CDM documents referencing coding-related activities
• Support and manage MedDRA and WHO Drug Dictionary upversion activities, including third-party vendor-operated studies
• Ensure compliance with industry quality standards, regulations, guidelines and procedures

Senior Medical Coding Specialist

Project Assistant

• Support IDEA project managers and teams by scheduling meetings, preparing agendas, and documenting action items and meeting minutes
• Manage project documentation and ensure files, records, and data are up to date and accessible
• Coordinate communication between cross-functional teams and departments
• Track project timelines, milestones, and deliverables and address issues that arise
• Assist with preparing reports, presentations, and other materials to support project progress and decision-making

Clinical Research

• Lead clinical trial monitoring tasks with a focus on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Conduct site visits to assess performance, resolve issues, and support successful trial execution
• Collaborate with cross-functional teams on timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain relationships with site personnel and stakeholders
• Work in a sponsor-dedicated FSP model with a focus on Oncology, preferably Phase I

Senior Clinical Research Associate

• Lead the collection, evaluation, and processing of adverse event reports in accordance with regulatory guidelines and company policies
• Conduct data analysis and interpretation of safety data, identifying trends and potential safety signals
• Prepare and submit periodic safety update reports (PSURs) and other regulatory documents
• Collaborate with medical and clinical teams to assess the clinical relevance of adverse events and contribute to risk management activities
• Oversee the maintenance and integrity of pharmacovigilance databases
• Provide training and mentorship to junior team members
• Engage in regulatory audits and inspections, ensuring readiness and compliance

Senior Pharmacovigilance Associate

Project Manager

• Lead and manage IDEA projects, including developing project plans, schedules, and budgets to ensure successful execution and delivery
• Collaborate with teams across innovation, data science, and technology to define project objectives, requirements, and deliverables
• Monitor project progress, identify potential risks and issues, and implement solutions to keep projects on track and within scope
• Facilitate communication between project teams and stakeholders, provide regular updates on project status, and ensure alignment with strategic goals
• Support the integration of emerging technologies and innovative solutions
• Manage day-to-day Independent DMC and Endpoint Adjudication activities, supporting the team to deliver quality outcomes

Project Manager – Independent DMC, Endpoint Adjudication

• Oversee and manage clinical trial activities for sponsor-dedicated Phase I Oncology trials
• Lead clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Conduct site visits to assess site performance, resolve issues, and support successful trial execution
• Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain effective relationships with site personnel and stakeholders

• 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

Study Start Up Associate I

Medical Director

• Lead medical affairs delivery across the portfolio, setting standards and developing the team
• Provide strategic medical leadership and guidance on project teams
• Offer expert medical and scientific consultation throughout project lifecycles
• Ensure compliance with ethical, legal, and regulatory standards in medical and safety monitoring activities
• Represent the Medical Affairs Department in business development initiatives
• Provide operational oversight within the Medical Affairs Department as needed

Manager

• Manage day-to-day finance and financial and contract management activities
• Draft and negotiate work order agreements, change order amendments, loan equipment agreements, non-disclosure agreements, and requests for proposals
• Review, revise, and manage consulting, supplier, distributor, clinical, service, and other non-standard agreements
• Escalate complex legal and factual matters to Legal and support issue resolution
• Oversee contract lifecycle management, including maintaining contract files, managing the contract request system, tracking deliverables, and generating reports
• Partner with business teams to prepare and execute CDA and NDA agreements
• Lead onboarding and training for new Contract Managers
• Train internal stakeholders on contract management systems and processes
• Facilitate weekly and monthly contract status meetings
• Prepare contract summaries and ensure compliant execution within service-level turnaround times
• Support business contract requests and monitor execution timelines
• Secure required internal approvals before execution
• Identify and implement process improvements to enhance efficiency and compliance

Manager, R&D Contract & Budget Management

• Support the management and monitoring of clinical trial sites
• Ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines
• Coordinate monitoring activities at clinical trial sites and resolve site-related issues
• Assist in preparing and reviewing regulatory documents
• Collaborate with cross-functional teams throughout the study lifecycle
• Track site performance metrics, analyze data, and provide reports
• Participate in training initiatives and mentor junior staff

Site Management Associate II

• Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials
• Ensure protocol compliance, data integrity, and patient safety throughout the trial process
• Collaborate with investigators and site staff to facilitate smooth study conduct
• Perform data review and resolution of queries to maintain high-quality clinical data
• Contribute to the preparation and review of study documentation, including protocols and clinical study reports
• Design and analyse clinical trials, interpret complex medical data, and contribute to the advancement of innovative treatments and therapies

Clinical Research Associate II

• Lead the analysis, interpretation, and management of clinical data to support clinical trial success
• Oversee clinical data science workstreams and ensure deliverables meet quality and timeline expectations
• Develop and implement clinical data management strategies for data collection, analysis, and reporting
• Collaborate with cross-functional teams to integrate data science techniques into clinical trial designs
• Oversee clinical data analysis to provide actionable insights for study decisions and outcomes
• Provide strategic guidance on data governance, quality control, and regulatory compliance
• Establish partnerships with stakeholders to leverage advances in data science and technology in clinical research
• Manage competing priorities and develop the team

Clinical Nurse Reviewer – Independent DMC and Endpoint Adjudication

Clinical Data Science Lead

Study Start up Associate II

Senior Medical Coding Specialist

Project Assistant

Senior Clinical Research Associate

Senior Pharmacovigilance Associate

Project Manager – Independent DMC, Endpoint Adjudication

Senior Clinical Research Associate

Study Start Up Associate I

Medical Director

Manager, R&D Contract & Budget Management

Site Management Associate II

Clinical Research Associate II

Senior Clinical Data Science Lead