ICON plc

Clinical Research

• 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 all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.

Clinical Trial Manager – Sponsor Dedicated

Affiliate Manager

• Accountable for the proficient and proactive co-ordination of all necessary activities required to achieve timely site activations and maintenance tasks for any given site(s) across a single or multiple studies.
• Act as site liaison and escalation point of contact; proactively resolving issues to ensure the site receives a positive customer experience.
• Ensure CDP and Site Activation approval dates are forecast and planned accurately in ICON’s systems, documenting all risks to delivery with mitigations taken, as they occur.
• Collect and collate site Critical Package Documents (CDPs) for review and approval prior to site activation in accordance all requirements, ensuring the highest quality, accuracy and completeness of site and country documentation is obtained in the TMF.
• Drive CDP and site activation timelines and ensure they are reflected accurately in ICON’s systems and are achieved; proactively follow through for achievement to plan; provide risk assessment and contingency plans at a site level, to mitigate impact if forecasted timelines are at risk; escalate issues as soon as identified.
• Ensure timely submission of protocol and study documents/safety reports for local ethics/IRB approval according to local requirements.

Senior Site Partner

Software Engineer

• Developing and validating R programs for statistical analysis and reporting of clinical trial data.
• Collaborating with biostatisticians to define analysis plans and statistical methods to be applied to clinical data.
• Performing quality control checks on statistical outputs and ensuring accuracy and consistency in reporting.
• Assisting in the preparation of statistical reports, presentations, and publications for regulatory submissions.
• Contributing to process improvements by identifying efficiencies in programming practices and methodologies.

Senior Statistical Programmer, Pharmacometrics – PK, NONMEM

Administration

• Collect, review, and track study documents.
• Help set up, maintain, close, and archive the Trial Master File (TMF), including regular quality checks.
• Support the creation and management of study documents, making sure they follow templates and are ready for regulatory publishing.
• Keep information up to date in tracking systems and communication tools and help team members use these systems.
• Coordinate and track study materials and equipment.
• Assist with tracking and reconciling invoices.
• Provide study metrics and reports for audits and regulatory inspections.
• Organize and help prepare meetings (study team, monitor, investigator, advisory boards).
• Communicate with internal and external team members, vendors, and investigators.
• Prepare and share study-related correspondence and materials for meetings, newsletters, and websites.

Global Study Administrator – GSA

Financial Planning and Analysis

• Develop scalable data models, KPIs, visualizations, and reporting frameworks aligned with business needs.
• Collaborate closely with the IT team to design, develop, and implement tailored reporting solutions that meet specific business requirements.
• Work closely with cross‑functional teams to understand reporting requirements.
• Support scenario analysis, trend analysis, and predictive insights as required by the business.
• Ensure continuous enhancement of dashboards and reporting solutions for improved usability, performance, and insight quality.
• Oversee the accuracy, completeness, and reliability of all existing reports under the reporting function.
• Ensure all recurring and ad‑hoc reports are delivered on time, with zero compromise on data quality.
• Implement checks, controls, and review processes to maintain high reporting accuracy.
• Proactively identify issues, gaps, or inconsistencies and drive corrective actions.
• Lead and mentor a small team of reporting analysts Assign responsibilities, monitor workloads, and ensure team deliverables are met within defined timelines.
• Provide coaching to improve team members’ technical skills, report accuracy, and business understanding.
• Foster a culture of accountability, continuous improvement, and quality reporting.
• Deliver clear, impactful data presentations to senior leadership and C‑suite executives.
• Translate complex data into compelling narratives tailored for business decision‑making.

Finance Manager

Manager

• Establishes and maintains oversight of 3rd party IRT vendor.
• Works directly with study teams to gather requirements and ensure IRT system is developed in line with study protocol.
• Develops and manages system deployment timelines for IRT.
• Manages IRT documentation which include but is not limited to: requirements, user guides, training materials, and communication plans.
• Coordinates user acceptance testing.
• Manages the deployment of IRT applications with internal teams and contract vendor.
• Provides guidance related to contracted vendors’ functionality, performance, and processes.
• Works with Clinical Logistics and Biostats on the upload of key information (i.e., subject randomization and kit lists, etc.)
• Oversees routine meetings with contract vendor regarding performance, issues identification/resolution, and risk management.
• Confirm effective training plans for IRT systems are developed for clinical teams and site personnel with the contract vendor.
• If required, attend Investigator Meetings or CRA Trainings to discuss system functionality and requirements.

IRT Manager, Clinical Supply Systems

• Building and maintaining strong, long-term relationships with key investigator sites, acting as their primary ICON point of contact.
• Supporting sites across multiple studies by facilitating communication, addressing operational challenges, and escalating issues as needed.
• Collaborating with clinical operations, feasibility, and project teams to align site capabilities with study opportunities.
• Gathering and sharing site feedback and insights to inform protocol design, feasibility assumptions, and process improvements.
• Monitoring performance metrics for partnered sites, including start-up timelines, recruitment, and quality, and driving improvement actions.
• Contributing to site engagement strategies, tools, and best practices to enhance the overall site experience.

Data Scientist

• Leading Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity.
• Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution.
• Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) and submission readiness of the clinical data management deliverables and data packages (e.g. CDISC).
• Project management of all clinical data management related deliverables including operationalization by steering internal and external experts and specialist.
• Ensuring adherence to planned time, cost and quality.
• Execution of the clinical data collection strategy in accordance to Sponsor Standards.
• Accountable for oversight of CROs in the execution of Phase I - IV clinical trial(s).
• Represents Data Management within the Global Trial Team and serves as the key Global Development Operations point of contact for the DM related tasks in a trial/project/program.
• Key contributor to the development of reports and communicating to relevant line management and Clinical Operations Teams.
• Drives, leads and manages the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials using strong project management, leadership, and organizational skills.
• Ensures strong oversight, review and delivery of trial/project DM related CAPAs in order to meet corporate compliance standards and timelines.
• Provides leadership and contributes to all operational aspects of the DM related trial budget, including forecasts to ensure delivery within the R&D financial standards.
• Performs review and provides strong operational input in the development of Clinical Trial Protocols, Integrated Analyses Plan and CSRs.

Associate Director, Clinical Data Manager

• Accountable for the proficient and proactive co-ordination of all necessary activities required to achieve timely site activations and maintenance tasks for any given site(s) across multiple studies.
• Act as site liaison and escalation point of contact; proactively resolving issues to ensure the site receives a positive customer experience.
• Ensure Critical Document Package (CDPs) and Site Activation approval dates are forecasted and planned accurately in ICON’s systems, documenting all risks to delivery with mitigations taken, as they occur.
• Collect and collate site CDPs for review and approval prior to site activation in accordance with all requirements, while ensuring the highest quality, accuracy and completeness of site and country documentation is obtained in the Trial Master File.
• Ensure timely submission of protocol and study documents/safety reports for local ethics/IRB approval according to local requirements.
• Prepare, collect and collate all requirements for site CDPs for review and approval prior to site activation in accordance with ICON SOPs/WPs, Sponsor requirements, applicable country regulations/guidelines and the principles of ICH/GCP, ensuring the highest quality, accuracy and completeness of site and country documentation is obtained in the TMF.
• Serve as internal expert consultant in regards to assigned key Institutions and sites to build relationships and internal data repository.

Site Partner II

• 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.

Senior Clinical Trial Manager – Internal Medicine

Clinical Operations

• Leading the operational planning and execution of clinical trials, ensuring adherence to protocols and timelines.
• Engaging with cross-functional teams to optimize trial design and enhance operational efficiency throughout the clinical development process.
• Monitoring trial progress and performance metrics, providing insights to inform decision-making and drive continuous improvement.
• Mentoring and developing junior staff, fostering a culture of collaboration and excellence within the team.
• Building strong relationships with internal and external stakeholders to facilitate smooth communication across clinical operations.

Manager, Clinical Operations

• Develop, validate, and maintain programming solutions for CDMS (EDC systems such as Rave and Veeva), data validation/analytic outputs, data review/risk management outputs, custom reports, and programs in clinical trials
• Develop and maintain programs required for handling external vendor data
• Perform extracts of data from CDMS and create data transfer programs
• Collaborate with data managers, project managers, and biostatisticians, among other positions, to ensure the integration of programming solutions into the overall data management process
• Act as a primary point of contact during the study set up and maintenance phase for system programming related questions by the project team
• Actively participate in internal and external meetings and provide constructive feedback to peers, team leads, and functional management.
• Act as mentor and provide ad hoc guidance, training, and support to other programmers
• Support knowledge sharing within the Programmers group through presentations and preparation of training materials.
• Assist in the development and implementation of improvements to technical systems and processes within an SME role
• Stay updated on advancements in programming languages and data management tools to enhance operational efficiencies

Principal Clinical Data Science Programmer

• Leading the design and execution of clinical studies, ensuring adherence to protocol and regulatory requirements.
• Collaborating with cross-functional teams to develop study protocols, informed consent forms, and study reports.
• Analyzing clinical data and interpreting results to support decision-making and regulatory submissions.
• Providing scientific input and strategic guidance throughout the clinical development process.
• Establishing partnerships with key stakeholders to ensure alignment on study objectives and outcomes.

Clinical Scientist II

QA Engineer

• Leading the development and implementation of quality assurance strategies and processes to support clinical trial activities.
• Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines.
• Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed.
• Providing expert guidance and support to staff regarding quality assurance policies, procedures, and best practices.
• Contributing to the continuous improvement of quality management systems and documentation.

Director, Quality Assurance

• Leading the design and implementation of data science strategies to enhance clinical trial data analysis.
• Collaborating with cross-functional teams to identify key data requirements and analytical needs.
• Overseeing the development of statistical models and analytical tools to optimize data interpretation.
• Mentoring and guiding team members in best practices for data analysis and visualization.
• Communicating findings and insights to stakeholders through presentations and reports, influencing project direction.

Clinical Trial Manager – Sponsor Dedicated

Senior Site Partner

Senior Statistical Programmer, Pharmacometrics – PK, NONMEM

Global Study Administrator – GSA

Finance Manager

IRT Manager, Clinical Supply Systems

Senior Site Partner

Associate Director, Clinical Data Manager

Site Partner II

Senior Clinical Trial Manager – Internal Medicine

Manager, Clinical Operations

Principal Clinical Data Science Programmer

Clinical Scientist II

Director, Quality Assurance

Clinical Data Science Lead