ICON plc

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 II

Content Writer

• Prepare informed consent documents that disclose information about a clinical trial using health literate language
• Work across multiple therapeutic areas using MSD tools, systems, guidelines, templates, and processes
• Manage informed consent writing projects including design, planning, and preparation of documentation in support of clinical development
• Read and understand protocol-specific design, objectives, and study procedures
• Collaborate with protocol authors to ensure comprehensive understanding of protocol details.
• Resolve document issues relating to informed consent.
• Participate in clinical trial team meetings to ensure timely delivery of documents
• Support tool development, enhancements, and testing, as applicable

Informed Consent Writer

Data Scientist

• 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.

Senior Lead Data Manager

Project Manager

• Accountable for driving and accelerating the activation of global investigative sites in line with, or ahead of, the study's contractual timelines, within budgeted resources, with quality output, and exceeding sponsor expectations.
• Accountable for the overall coordination, implementation and completion of site activation or maintenance activities for assigned projects of work in line with ICON/sponsor SOPs as appropriate, including regulatory/ethics, site contracts, essential documents, and site activations.
• Interacts with internal teams and stakeholders, as well as sponsor teams and stakeholders as needed.
• Lead studies with highest quality standards to exceed customer expectations.
• Review study and partnership budgets for proposals and sales as needed.
• Drive assigned studies to meet KPIs and delight customers and sites.
• Act as customer point of contact for assigned studies; resolve study issues and drive exceptional customer delivery.
• Represent FSA at audits and inspections.
• Participate in Business Development opportunities to support the growth of the assigned portfolio, function, and/or region/country(ies).

Project Manager, Feasibility Site Activation

• Developing, validating, and maintaining programming solutions for data analysis and reporting in clinical trials.
• Collaborating with clinical data scientists and biostatisticians to ensure the integration of programming solutions into the overall data management process.
• Overseeing the generation of statistical datasets, tables, listings, and figures to support regulatory submissions and study reports.
• Providing guidance on programming best practices, coding standards, and data quality control measures.
• Staying updated on advancements in programming languages and data management tools to enhance operational efficiencies.

Senior Clinical Data Science Programmer

Clinical Research Associate – French / German Speaking

• Serve as a technical expert in building data pipelines for the ingestion and delivery of clinical data at the study level, supporting study start-up, conduct, and close-out activities.
• Develop robust data pipelines for integrating heterogeneous data sources.
• Identify, design, and implement scalable data delivery solutions, automating manual processes whenever possible.
• Develop and implement comprehensive data integrity and quality checks throughout the data ingestion process.
• Design and build infrastructure for optimal data extraction, transformation, and loading (ETL/ELT) using cloud platforms such as AWS and Azure.
• Collaborate with downstream users—including statistical programmers, SDTM programmers, analytics, and clinical data programmers—to ensure deliverables meet end-user requirements.
• Appropriately escalate issues to CDE leadership as needed.

• Works on multiple trials within the Cross Therapeutic areas - Start up focus
• Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
• Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies.
• Build strong relationships with site personnel to facilitate a smooth onboarding process.
• Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).
• Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation.
• Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process.
• Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities.
• Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.
• Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.
• Proactively identify and address any issues that may delay study initiation or affect trial deliverables.
• Maintain precise documentation to ensure readiness for inspections.
• Support sites during the activation phase until they achieve “Green Light” status for site opening.
• Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met.
• Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards.

Clinical Research Associate, Multi TA

Software Engineer

• Developing and validating SAS 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

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.

Senior Clinical Trial Manager

• Designing, developing, and validating SAS programs/R-Shiny applications for statistical analysis and reporting of clinical trial data.
• Working closely with biostatisticians to create comprehensive analysis plans and apply appropriate statistical methods.
• Performing quality control checks and reviewing statistical outputs to ensure compliance with project specifications and regulatory guidelines.
• Assisting in the preparation of statistical reports, presentations, and regulatory submissions to support clinical development programs.
• Mentoring junior programmers and contributing to team development by sharing best practices and technical knowledge.

Senior Statistical Programmer II

• Designing, developing, and validating SAS programs for statistical analysis and reporting of clinical trial data.
• Working closely with biostatisticians to create comprehensive analysis plans and apply appropriate statistical methods.
• Performing quality control checks and reviewing statistical outputs to ensure compliance with project specifications and regulatory guidelines.
• Assisting in the preparation of statistical reports, presentations, and regulatory submissions to support clinical development programs.
• Mentoring junior programmers and contributing to team development by sharing best practices and technical knowledge.

Statistical Programmer II

Manager

• Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness.
• SM works in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study setup to study archival.
• Focus on setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP).
• Works cross-functionally, with internal and external partners, on clinical study management activities, for in-house and outsourced studies across all phases and therapeutic areas.
• Responsible for monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline and budget objectives.

Global Delivery Manager

Clinical Research Associate

Business Development Rep

• Increase market awareness, sales and profitability by increasing the number of new Requests for Proposals (RFPs)
• Work closely with Account Executives and engagement partners to create a plan to enhance new account penetration, meetings, and RFPs
• Call new and existing accounts and schedule meetings for the business development team
• Regularly follow-up with prospective clients to build meaningful relationships
• Maintain and manage CRM with all activity
• Generate reports to highlight RFPs, meetings, and new account penetration
• Research accounts and identify new opportunities for ICON
• Provide updates to the business development team on activity and conversations with clients
• Generate client interest for potential webinars, industry meetings and conferences
• Review metrics on a regular basis to assess productivity
• Attend internal meetings to discuss new opportunities and the sales pipeline
• Support the preparation for client meetings
• Develop a sales methodology and strategy for increasing new account penetration
• Learn messaging around ICON’s differentiators
• Lead calls and participate in client meetings
• Execute against a specific account plan; routinely achieving quarterly objectives

Clinical Research Associate II

Informed Consent Writer

Senior Lead Data Manager

Project Manager, Feasibility Site Activation

Senior Clinical Data Science Programmer

Clinical Research Associate – French / German Speaking

Senior Clinical Data Science Programmer

Clinical Research Associate, Multi TA

Senior Statistical Programmer

Senior Clinical Trial Manager

Senior Statistical Programmer II

Statistical Programmer II

Global Delivery Manager

Clinical Research Associate

Business Development Associate, French Speaking