ICON plc

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

Software Engineer

• May be the primary point of contact during the study set up phase for system programming related questions by the project team.
• Independently performs reviews of database specifications, and programs in at least one to two Clinical Data Management and/or Electronic Data Capture systems
• Reviews other study-related documents and helps to support comments from the study team and client
• Build and maintain collaborative working relationships with stakeholders in order to elicit business requirements, identify dependencies and support the creation of specifications for most medium-to-high complexity data review and analytic outputs.
• Program most medium-to- high complexity data ingestion, CDMS, data review/risk management outputs, custom reports and programs
• Communicate most medium-to -high complexity analytics requirements and solutions effectively to other team members and stakeholders
• May program clinical study database screens (eCRF) per provided specifications.
• Design and build cross-page visualization solutions in analytics tools; build information models, including database write-back; write R and python scripts as required.
• Performs data refreshes of data review and analytics outputs as needed and provides feedback on any discrepancies.
• Tracks and keeps functional management and those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalates potential problems effectively and in a timely manner.

Visualisation Developer

Clinical Research

• Leading the design and execution of clinical trial protocols, ensuring alignment with scientific and regulatory guidelines.
• Monitoring patient safety and overseeing the clinical aspects of trials to ensure compliance with GCP standards.
• Collaborating with cross-functional teams to analyze study data and provide medical insights that guide decision-making.
• Engaging with investigators and study sites to ensure adherence to protocols and facilitate successful trial execution.
• Contributing to the preparation of regulatory submissions and clinical study reports.

Clinical Research Physician

Medical writer

• Provide scientific and medical/clinical writing support for late-phase projects
• Write and review study documents such as Protocol, Synopsis, Informed Consent, Data Collection Documents and Study Report
• Develop scientific communication materials such as abstract, poster, manuscript
• Perform quality control for medical writing deliverables
• Interpret statistical results and collaborate with statisticians
• Improve the quality assurance system
• Participate in bid-defence presentations for medical writing activities

Senior Medical Writer

Recruitment

• Developing and executing comprehensive patient recruitment strategies tailored to specific clinical trial objectives, ensuring alignment with study protocols and timelines.
• Leading cross-functional teams in the identification and engagement of target patient populations, utilizing data-driven insights to optimize recruitment efforts.
• Building and maintaining partnerships with healthcare providers, patient advocacy groups, and community organizations to enhance recruitment and retention strategies.
• Analyzing recruitment metrics and performance data to identify trends, challenges, and opportunities, making data-informed recommendations for improvement.
• Creating and overseeing the development of patient-centric marketing materials and outreach campaigns to effectively communicate trial benefits and address patient concerns.
• Providing training and guidance to project teams and staff on recruitment best practices, tools, and techniques to enhance recruitment success.
• Staying informed about industry trends, regulatory guidelines, and emerging technologies that impact patient recruitment and engagement.
• Monitoring recruitment progress and outcomes, reporting on successes and challenges to senior leadership and stakeholders.

Patient Recruitment Manager

Director

• Providing strategic leadership for of first-in-human, early patient and clinical pharmacology studies, including risk assessment, pharmacokinetics, pharmacodynamics, and exposure-response modeling.
• Collaborating with cross-functional teams to integrate optimal clinical trial design and clinical pharmacology insights into clinical development programs and trial designs.
• Overseeing the analysis and interpretation of pharmacology data to inform dose selection, safety, and efficacy assessments.
• Providing strategic guidance on trial design and data analysis, with awareness of use of modeling and simulation techniques to optimize clinical trial designs and accelerate development timelines.
• Establishing and maintaining partnerships with internal and external stakeholders, including regulatory agencies and key opinion leaders, to ensure alignment on clinical pharmacology strategies.

Director, Clinical Pharmacology

• Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Leads or supports cross-functional trial teams, including vendors
• Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues
• Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data
• Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team
• Participate in or lead feasibility assessment and selection of countries and sites for trial conduct
• Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
• Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
• Provide oversight and direction to trial team members for trial deliverables
• Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems
• Ensure quality and completeness of TMF for assigned clinical trials
• Participates in inspection readiness activities including coordination of clinical trial team deliverables
• Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable
• Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities

Clinical Trial Manager II, Oncology

Accounts Payable

• Leading the accounts payable team to ensure timely and accurate processing of invoices, payments, and expense reports.
• Developing and implementing efficient accounts payable processes and procedures to streamline operations.
• Maintaining vendor relationships and resolving any issues or discrepancies in a professional and timely manner.
• Overseeing month-end and year-end accounts payable closing processes.
• Discussing with other departments to resolve invoice discrepancies and ensure accurate financial reporting.

Manager, Accounts Payable

Program Manager

• 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.
• Review of vendor related protocol sections during protocol development
• Contribute to the development of vendor contract amendments

Vendor Program Manager

• 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 – Biotech

• Be responsible to function in a continuous improvement framework with respect to systems deployment, life cycle management and enhancements supported user groups.
• Contribute to initiatives to yield faster and more effective report development, efficient change management services for analytics platforms.
• Use your technical expertise with clinical data and report building, and experience gained through working with diverse and complex business processes and associated system infrastructures.
• Work in a matrix environment across functions and departments

Administration

• You will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality.
• Play a key role in the safe, efficient and effective Investigational Product preparation and administration in clinical trials.
• Review and provide input on Investigational Product Preparation Instructions Site Investigational Product Procedures Manual, monitoring guidelines and all specific forms related to Investigational Product preparation and dosing before finalization as applicable.
• Process risk assessment review where applicable.
• Close collaboration with the Drug Product Development team and the Drug Preparation Administration Team.
• Early connection with investigational site pharmacy and nursing staff to review site IP process and equipment.
• Close collaboration with (Global Trial Lead) GTL, (Study Manager) SM, (Trial Manager) TM, Independent Drug Monitor (IDM) and Pharmacy Investigational Product Specialist (PIPS) for all IPPI related topics.
• Evaluate and support process for IP ancillary supplies/administration kits are compatible with the site equipment/practice in the country/investigational site.
• Review of site's dispensing and accountability records to ensure key information is captured to confirm dose delivery and administration is documented e.g. infusion rates/volumes.
• Collaboration on Investigational Product training material development with key stakeholders.
• Observe first dosing on site and/or support SM/IDM/PIPS if allowed according to local guidelines and blinding requirements.
• Point of contact for the internal study team in the country for questions related to the IP administration.
• Review any modification of IPPI, SIPPM manual, specific forms related to IP administration and dosing during the applicable phases of the trial.
• Establish and maintain good and productive working relationships with internal and external stakeholders (e.g. nurses, investigators,…).

IP Administration, Nurse

• Conducting statistical analyses and data visualizations to identify trends and patterns in clinical trial data.
• Collaborating with cross-functional teams to ensure data integrity and adherence to study protocols.
• Assisting in the development of analytical models and tools to improve data analysis processes.
• Preparing reports and presentations that effectively communicate findings to stakeholders.
• Staying updated on industry trends and advancements in data science to contribute to innovative practices.

Clinical Data Science Associate

• Ensures the safety of participants and promotes the mission of Accellacare
• Actively recruits and promotes service to suitable participants and sponsor representatives
• Performs tasks required to coordinate and complete multiple studies according to the protocol
• Assists the Manager of Clinical Operations and Sr. Clinical Research Coordinators with staff development through mentoring and site level quality assurance.
• Performs study start-up duties including the production of a recruitment tool and progress notes
• Proactively develops and executes recruitment plans that meet and exceed enrollment goals
• Accurately collects study data via source documents/progress notes
• Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits.

Clinical Research Coordinator

• Leading the strategic planning, development, and implementation of clinical systems, including Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and other technologies supporting clinical trials.
• Overseeing the integration and optimization of clinical systems to ensure seamless data flow, operational efficiency, and compliance with regulatory standards.
• Collaborating with cross-functional teams, including clinical operations, data management, and IT, to define system requirements, address operational challenges, and drive continuous improvement.
• Providing strategic direction on system selection, implementation, and maintenance, ensuring alignment with study objectives, data quality standards, and organizational goals.
• Staying abreast of industry trends and technological advancements to drive innovation in clinical systems and enhance trial management and data analysis capabilities.

Program Manager, Clinical Data Science

Visualisation Developer

Clinical Research Physician

Senior Medical Writer

Patient Recruitment Manager

Director, Clinical Pharmacology

Clinical Trial Manager II, Oncology

Manager, Accounts Payable

Vendor Program Manager

Clinical Trial Manager – Biotech

Visualisation Developer

IP Administration, Nurse

Clinical Data Science Associate

Clinical Research Coordinator

Senior Director, Clinical Systems