ICON plc

Research Analyst

• You will be responsible for meeting/greeting clinical research volunteers as they come into the clinic, checking their vitals (height, weight, blood pressure, BMI), and essentially making sure the study participants are healthy enough to participate in the clinical trial according to the protocol of a study.
• Your compassion and dedication will be at the forefront as you take vital signs and perform phlebotomy on study subjects, ensuring their comfort and well-being throughout the research process.
• You will be entrusted with following our clients' protocols when conducting vital sign assessments and phlebotomy procedures.
• Joining us means being part of a collaborative environment where your active participation in meetings and other assignments will be valued and recognized.
• Your role will extend beyond the clinical aspects as you chaperone study subjects during their breaks outside, offering personalized care and ensuring their comfort.

Medical Research Associate

Data Engineer

• 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.

Clinical Data Engineer

Clinical Research

• Work with interdisciplinary teams to develop and implement clinical trial protocols.
• Conduct and coordinate clinical trial activities, ensuring adherence to regulatory requirements and ethical standards.
• Administer investigational drugs and monitor patient reactions during clinical trials.
• Collect and manage clinical trial data, ensuring accuracy and completeness.
• Provide patient education and support, fostering a positive and collaborative research environment.

Clinical Research Nurse I

Manager

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
• Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organizes regular Local Study Team meetings on an agenda driven basis.
• Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
• Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.
• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
• Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
• Plans and leads National Investigator meetings, in line with local codes, as required.
• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level.
• Ensures accurate payments related to the study are performed according to local regulations and agreements.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and Procedural Documents.
• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline bmanner to maintain the eTMF “Inspection Ready”.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.
• Provides input to process development and improvement.
• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
• Updates Line Managers about the performance of the CRAs/CSAs.
• Ensures that study activities at country level comply with local policies and code of ethics.
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Ensures compliance with company Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Collaborates with local Medical Affairs team.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Local Trial Manager

Therapist

• Lead and coordinate a cross-functional study team of experts in accordance with SDO/STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards.
• Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection.
• Assist the (Sr)GPD with the operational planning for upcoming clinical studies to establish required number of resources for study conduct, interfacing with other cross-functional partners and the TA as required.
• Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended).
• Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan.
• For outsourced studies, be the primary point of contact for the CRO Study Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations).
• Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant
• Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities.
• Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.), ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team.
• Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations.
• Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.).

Global Study Director – Hematology/Oncology – Cell Therapy

Data Scientist

• Managing the end-to-end execution of clinical data science programs, including planning, resource allocation, and delivery of data science projects within scope, time, and budget constraints.
• Coordinating with data scientists, statisticians, clinical researchers, and other stakeholders to ensure alignment on project objectives, data requirements, and analytical approaches.
• Developing and maintaining program plans, timelines, and budgets, and monitoring progress to ensure timely and successful completion of data science initiatives.
• Providing strategic oversight and guidance on data science methodologies, ensuring that analyses are rigorous, valid, and aligned with clinical and regulatory standards.
• Communicating program status, insights, and outcomes to stakeholders, including executive leadership, and addressing any issues or risks that may impact program success.

Program Manager, Clinical Data Science

QA Engineer

• Leading and supporting external audits of ICON including scheduling, preparation and hosting.
• Leading CAPA management for external audits of ICON and/or investigator sites, where needed, in order to assure responses are compliant with ICON or Sponsor SOP requirements.
• Leading CAPA management for sponsor audits of ICON, including liaising with ICON operation teams to ensure timely completion of audit responses, supporting operations to ensure responses are appropriate, including ensuring appropriate corrective and preventative actions are implemented and liaising with the client to deliver responses within the agreed timelines and respond to any resulting follow-up.
• Leading quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented.
• Ensuring CAPAs are formally recorded and reported and actions are documented and followed until resolution.
• Identify and track required effectiveness checks and ensure checks are completed within the required timelines.
• Providing advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements.
• Supporting other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and/or vendors, when deemed necessary.

Senior Auditor, QA – Client Management Team

Affiliate Manager

• Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
• Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Maintaining accurate and up-to-date records of regulatory submissions and approvals.
• Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
• Participating in study start-up meetings and providing input on regulatory requirements and timelines.

Site Activation Partner

Software Engineer

• Developing, validating, and maintaining complex statistical programs (SAS, R, or similar) for data manipulation, analysis, and reporting in clinical trials.
• Collaborating with biostatisticians and cross-functional teams to interpret study requirements and ensure the accurate implementation of statistical analyses.
• Preparing and reviewing statistical analysis plans (SAPs), programming specifications, and derived datasets to meet regulatory standards.
• Ensuring data integrity and compliance with industry regulations, including ICH/GCP guidelines, throughout the programming process.
• Mentoring junior programmers and assisting in training team members on programming techniques and best practices.

Statistical Programmer

Medical Billing and Coding

• Performing advanced medical coding of diagnoses, procedures, and medications using standard coding systems such as MedDRA and WHO Drug.
• Ensuring coding accuracy, consistency, and compliance with regulatory requirements across multiple clinical studies.
• Collaborating with clinical and data management teams to resolve complex coding discrepancies and queries.
• Providing expertise in the development and refinement of medical coding conventions and procedures.
• Staying updated on changes in medical coding standards and ensuring their implementation in clinical trial processes.