ICON plc

Medical writer

• Collaborating with cross-functional teams to prepare, write, and edit clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), patient narratives, and other regulatory documents
• Conducting literature reviews, data analysis, and interpretation of clinical trial results
• Assisting in the review and validation of clinical data
• Participating in project meetings, teleconferences, and client interactions
• Keeping abreast of emerging trends, scientific developments, and regulatory updates in relevant therapeutic areas.

Medical Writer II

Data Scientist

• Leading the design, development, and validation of data science programming solutions for clinical trials.
• Collaborating with biostatisticians, data managers, and clinical teams to develop data specifications and analysis plans.
• Programming and validating datasets, tables, listings, and figures (TLFs) according to study requirements.
• Ensuring the accuracy, consistency, and integrity of clinical data through rigorous quality control and validation checks.
• Mentoring and guiding junior programmers and providing technical leadership within the data science programming team.

Senior Clinical Data Science Programmer

• Independently author most study-level documents at simple to complex levels, for example: Protocol, protocol outlines, Subject Information/Informed Consent, Clinical study reports (CSRs), Lay summaries of clinical trial results, Investigator brochures (IBs).
• Provide support to more experienced writers with the preparation of submission and other complex clinical documents.
• Capable of interpreting and summarizing data.
• Drive discussions, ensure decisions are taken and incorporate project strategies in documents.
• Lead meetings and drive decisions concerning project/trial-specific medical writing issues.
• Responsible for all medical writing aspects of task finalization including stakeholder alignment, coordination, and adherence to timelines.

Senior/Principal Medical Writer

• Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity.
• Perform medical writing tasks, especially medical writing tasks of high complexity and critical to project(s) and strategic area
• Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development.
• Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards.

Principal Medical Writer

Clinical Research

• Designing and implementing clinical trial protocols, ensuring adherence to scientific and regulatory standards.
• Conducting data analysis and interpretation to derive insights that support study objectives.
• Collaborating with cross-functional teams to ensure effective study execution and data quality.
• Engaging with stakeholders to communicate findings and contribute to scientific discussions.
• Assisting in the preparation of regulatory submissions, study reports, and scientific publications.

Clinical Scientist I

• 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

Research Analyst

• 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 – Cross Therapeutic

• 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

Senior Clinical Research Associate / Clinical Research Associate II

Human Resources

• Acting as a trusted HR partner to business leaders, providing guidance on workforce planning, performance, and organisational changes.
• Managing employee relations matters, ensuring fair, consistent, and compliant resolution in line with company policies and local legislation.
• Supporting talent management activities, including recruitment, onboarding, development planning, and succession discussions.
• Implementing HR programmes and initiatives that support engagement, diversity, equity, inclusion, and wellbeing.
• Advising on compensation, benefits, and reward practices in partnership with specialist HR teams.
• Using HR data and analytics to identify trends, inform decisions, and support continuous improvement.

HR Manager

Business Intelligence Analyst

• Leverage strong analytical skills to objectively interpret data from various sources, providing clear insights and actionable recommendations.
• Apply independent critical thinking to analyze problems, present data-driven solutions, and drive actions to meet business objectives.
• Validate and ensure the quality of data before initiating analysis, conducting quality checks on your work to maintain accuracy.
• Compose and deliver data outputs in a client-friendly manner, meeting established timelines and contractual requirements.
• Collaborate in the creation of dashboards and metrics, contributing your expertise to establish relevant Key Performance Indicators (KPIs).
• Communicate clearly with internal and external stakeholders, including senior management, to understand reporting and analytical requirements and provide relevant training and support.

Data & Reporting Analyst II

Manager

Local Trial Manager – FSP

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Clinical Research Associate

• Play a crucial role in effectively reviewing and approving visit reports as per annotated report, protocol, ICON and/or Sponsor SOPs and ensure errors are minimized.
• Ensure turnaround time of the visit reports per contract, ICON and or Sponsor SOP.
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a Manager, recognize the importance of and create a culture of process improvement with a focus on streamlining processes, adding value to business and meeting client needs.
• Regular oversight of OMR, ICOtrial (and where required Sponsor CTMS and vendor systems) to ensure key metrics are being met.
• Ensure open action items and protocol deviations are escalated and followed up for timely resolution.
• Where required, attend project meetings and actively provide suggestions for quality improvement of reports.
• Liaise with CTM to communicate any trends, outstanding issues, safety concerns or any other activity that may jeopardize the clinical trial delivery or patient safety.
• Ensure all necessary training required to improve job performance and knowledge are completed timely.
• Contribute towards quality improvement and risk management plans to minimize impact on project objectives and deliverables, and patient safety and show consistent improvement in metrics.
• Actively support staff with change management.
• Liaise with other managers to improve effectiveness of the organization.

Centralized Clinical Trial Manager

Supply Chain

• Recognize, exemplify and adhere to ICON's values
• As a member of staff, embrace and contribute to process improvement
• Ensure processes are carried out within agreed times
• Compliant with industry and international regulations
• Travel approximately 10% domestic and/or international
• Liaise with stakeholders on kit supply issues
• Review departmental operating issues with leaders
• Introduce new ideas for operational performance improvement
• Maintain oversight of kit production vendor metrics
• Document issues with inbound deliveries or couriers
• Create Proforma invoices based on shipment requirements
• Prepare and ship supplies to sites or other destinations
• Obtain pricing quotes from carriers for shipments
• Attend meetings providing guidance on import/export regulations
• Support QA team during audits with relevant information.

Medical Writer II

Senior Clinical Data Science Programmer

Senior/Principal Medical Writer

Principal Medical Writer

Clinical Scientist I

Clinical Trial Manager

Clinical Research Associate – Cross Therapeutic

Senior Clinical Research Associate / Clinical Research Associate II

HR Manager

Data & Reporting Analyst II

Local Trial Manager – FSP

Clinical Research Associate

Centralized Clinical Trial Manager

Clinical Research Associate

Global Supply Chain Specialist