ICON plc

Risk

• Conducting risk assessments on clinical trial data to identify potential issues and recommend mitigation strategies.
• Collaborating with cross-functional teams to develop and implement risk management plans and protocols.
• Monitoring data quality and integrity throughout the trial process, reporting findings to stakeholders.
• Utilizing statistical analysis and visualization tools to communicate risk-related insights effectively.
• Supporting the preparation of risk management documentation for regulatory submissions and audits.

Clinical Data Risk Analyst

Research Analyst

• 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

Clinical Research Associate

Designer

• Oversee the development and/or technical activities for EDC databases build - Main technical DB build contact to study data manager
• Work with Clinical Study Team through Study Data Manager to implement eCRFs in Rave Architect per protocol requirements
• Create study on Medidata URL; Rave User Administration and IRT account setup; Project registration in Rave Coder; AE/SAE alert code review; etc
• Leads in the support and review for the re-use of library items
• Organizes, creates, and oversees the administration of training and mentoring for junior levels.
• Collaborates with external professionals to troubleshoot process or implementation issues.

eCRF Designer

Analyst

• Collaborate with internal stakeholders to review, draft, and negotiate contracts for clinical research projects, ensuring alignment with regulatory requirements and company policies.
• Conduct thorough analysis of contract terms, conditions, and obligations to identify risks, opportunities, and areas for improvement.
• Provide guidance and support to project teams on contract interpretation, compliance issues, and contractual rights and obligations.
• Maintain accurate and organized contract records, tracking key milestones, deliverables, and deadlines.
• Assist in the development and implementation of contract management processes, procedures, and best practices to optimize efficiency and mitigate risks.

Senior Contract Analyst

Financial Planning and Analysis

• Preparation of group annual reports under US GAAP & IFRS.
• Preparation and reporting of quarterly financial reporting to the stock exchange under US GAAP.
• Preparation of monthly consolidated group management information for internal purposes.
• Provide accounting and regulatory guidance (both US GAAP & IFRS) to internal customers and stakeholders on key accounting issues impacting the business.
• Perform a key role in assessing the impact of any new accounting standards/regulatory changes and related implementation.
• Proficient in operating in and leading a strong SOX control environment, and providing guidance and direction to the wider group finance team for continuous improvement.
• Collaborate with internal customers and stakeholders to develop & continually improve processes & systems for both external and internal financial reporting.
• Work with interdisciplinary teams to develop and implement group strategy and projects (legal, tax, treasury, IT, finance).
• Support the integration of acquisition targets into the group finance structure.
• Support the preparation of statutory financial statements and the related audit process.
• Coach and mentor junior members of the group accounting team.

Director, Finance – Group Accounting and Reporting

• Consultation and advise on our group annual reports under both US GAAP & IFRS
• Review and approval of quarterly financial reporting to the stock exchange under US GAAP
• Consultation and advice on ad hoc accounting issues that arise in a group of the complexity and scale of ICON, Plc
• Input to technical analysis supporting our quarterly Audit Committee materials and other ad hoc Board materials as required
• Leading the group’s assessment and approach to any complex accounting issues, coordinating with external advisors as necessary
• Leading impact assessment & response implementation of any new accounting/legislative or other changes
• A key relationship and liaison for group audit process and play a leading role in resolution of any matters arising
• Leading response to any financial reporting regulatory correspondence
• Working with and supporting business unit and shared service finance colleagues on evaluating accounting impact of any accounting issues as they arise
• Working with group tax and treasury teams in on-going reviews of group structure
• Supporting legal & commercial finance teams in any ad hoc finance arrangements
• Leading pre-deal reviews of accounting implications of potential acquisition targets
• Consulting with the teams responsible for various statutory financial statements & audit processes
• Ensuring compliance with responsibilities as a NASDAQ listed group around internal control over financial reporting (SOX)

Senior Director, Finance – Group Accounting, Reporting

Manager

• Adapt global agreement templates for local use, ensuring alignment with local requirements and standard operating procedures.
• Develop and negotiate clinical site budgets based on Fair Market Value.
• Negotiate the language and budget terms of agreements with clinical study sites, engaging with site administration if needed, especially with partner sites.
• Serve as the primary point of contact with Legal, as required, to maintain contract integrity.
• Track and maintain the status of each agreement, including budgets, issues, payments, amendments, and all communications with internal and external parties for the duration of the study.
• Ensure final contract documents accurately reflect the agreements reached during negotiations.
• Guarantee timely execution of all agreements to contribute to efficient site start-up timelines.
• Support both internal and external audit activities.
• Ensure compliance with sponsor Code of Conduct and all company policies relating to people, finance, technology, and security.
• Ensure that all contracts are filed, maintained and archived within the electronic Trial Master File (eTMF).

Site Contracts Manager

• Developing and overseeing clinical risk management strategies, including risk assessment, mitigation planning, and monitoring to ensure the safety and integrity of clinical trials.
• Leading a team in identifying potential risks related to clinical trial operations, data integrity, and patient safety, and implementing effective risk management measures.
• Collaborating with cross-functional teams, including clinical operations, regulatory affairs, and data management, to integrate risk management strategies into overall clinical trial processes.
• Monitoring and analyzing risk-related data and trends, providing insights and recommendations to senior management to address potential issues and enhance risk management practices.
• Ensuring compliance with regulatory standards and industry best practices for risk management, including adherence to Good Clinical Practice (GCP) and other relevant guidelines.

Senior Manager, Risk-Based Quality Management

Clinical Research

• 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.

Clinical Trial Manager, Senior Clinical Trial Manager

Account Executive

• Work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
• Ensure a smooth process at all stages (proposal, bid defence) which maximises the opportunity for success.
• Promote DOCS as a preferred industry partner.

Senior Account Executive

Compliance

• Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, dispatch and coordinating resources for submissions.
• Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.
• This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing, publishing, production (paper and electronic), and archiving (paper and electronic), as applicable.
• Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
• Maintain submission components associated with a regulatory submission, paper and/or electronic, as required.
• This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking
• Assemble electronic and paper Regulatory Submissions and packages for Health Canada, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using specialty EDMS/publishing software.
• Perform quality review of Regulatory Operations team members work to ensure accuracy.
• Participate in submission teams, maintaining necessary liaison between both project leader, and when applicable, with client.
• Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required.
• Maintain current knowledge of applicable regulations and industry best practices.
• Participate in the interpretation of guidelines and impact assessment to current work procedures.
• Anticipate Regulatory consequences and advise project teams on publishing issues and strategies.
• Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and government agencies in a polite and professional manner.
• Assist in the design and implementation of new processes or initiatives within the department.
• Participate in special projects and carry out assigned activities in support of the Publishing function.

Senior Regulatory Operations Associate

• Works with Clinical Operations to understand clinical demand requirements and ensures alignment with study teams on clinical supply plans and timelines.
• Develop and maintain clinical supply forecasts (Within forecasting system N-Side) and inventory plans for assigned programs, ensuring alignment with upstream supply integrators.
• Maintain routine and timely communication with Investigational Material Supply Chain (IMSC) Integrators to discuss aggregate drug product demand, changes in clinical supply forecasts, and study timelines.
• Maintain routine and timely communication with Investigational Material Supply Chain (IMSC) Operations to discuss the planning and execution of all packaging and labeling work to support clinical trials.
• Coordinate sourcing of co-meds working closely with Procurement, Supply Vendors and Alliance Managers.
• Ensure delivery of co-meds to IMSC Operations for further packaging and distribution.
• Generate and monitor co-med budgets and spend working closely with Development Project Managers, Clinical Operations and Finance.
• Manages clinical supply inventory, develops inventory reports and monitors upcoming expiry for assigned programs.
• Align efforts among Project Management, Clinical Operations, and Technical Operations for the timing and delivery of clinical supplies for assigned programs.
• Facilitate discussions and decisions on label and packaging design, as needed.
• Support IRT user acceptance testing, develops IRT supply strategy, and oversees ongoing supply activities in the system.

Global Clinical Supply Manager

Medical Billing and Coding

• Accurately coding medical terms, diagnoses, and procedures using standard medical coding systems such as MedDRA and WHO Drug.
• Ensuring the consistency and accuracy of medical coding across multiple clinical trials.
• Collaborating with cross-functional teams to resolve coding discrepancies and provide coding-related guidance.
• Maintaining up-to-date knowledge of medical coding standards and regulatory requirements.
• Contributing to the development of coding conventions and processes to enhance the quality of clinical data.

Medical Coding Specialist

Project Manager

• Developing and managing FSA project plans, timelines, and deliverables for assigned studies.
• Coordinating feasibility assessments, country and site recommendations, and start-up strategies in collaboration with functional experts.
• Overseeing essential document collection, ethics and regulatory submissions, and site activation milestones.
• Tracking progress against timelines and KPIs, proactively identifying risks and implementing mitigation plans.
• Serving as the primary FSA contact for internal teams and customers for study-level start-up matters.
• Contributing to process improvement and best practice sharing within the FSA project management team.

Medical Director

• Medical Monitoring
• Support of Business Development opportunities as Therapeutic Expert in Neurology to win new projects, attend client calls, develop strategies and defend them in front of the client team during a Bid Defense Meeting
• Providing input into the creation of the protocol and other study-related documents
• Participating in discussions with regulators, key opinion leaders, senior management and our clients
• Delivering training to external project teams and ICON colleagues
• Reviewing medical data on the indication, inclusion / exclusion criteria and other medical issues to ensure our overall project deliverables are achieve
• Sharing your vast medical expertise at investigator meetings, kick-off meetings, and client face-to-face meetings
• Working closely with our Drug Safety teams to evaluate Serious Adverse Events and to develop Safety Management Plans, Pharmacovigilance Plans and Risk Management Plans
• Maintaining a strong consultative relationship with the client throughout the project life cycle