ICON plc

Data Scientist

• Leading the development and implementation of clinical data management strategies to optimize data collection, analysis, and reporting.
• Collaborating with cross-functional teams to ensure the accurate integration of data science techniques into clinical trial designs.
• Overseeing the analysis of clinical data to provide actionable insights that inform study decisions and outcomes.
• Providing strategic guidance on data governance, quality control, and compliance with regulatory requirements.
• Establishing partnerships with key stakeholders to leverage the latest advancements in data science and technology in clinical research.

Senior Clinical Data Science Lead

Account Executive

• Conduct comprehensive market research: map competitive landscape and identify potential FSP opportunities.
• Analyze industry trends, competitor strategies, and client needs to develop informed business development strategies.
• Create and execute global account strategies to achieve revenue and margin goals.
• Implement, maintain and update strategic plans to target and win FSP programs.
• Build out engagement plan with customers – map out client organizations and identify key decision makers.
• Negotiate and secure agreements to win FSP work.
• Build and maintain strong relationships with key decision-makers at Sr level and leadership/ operational level.
• Lead the development of targeted proposals and presentations for FSP opportunities.
• Work closely with ICON operations, finance, and legal, to ensure alignment on FSP strategies and ensure the FSP pricing is competitive and makes sense.
• Attend industry conferences, seminars, and networking events to build relationships and stay informed about market developments.
• Mentor and train junior business development team members.

Senior Account Executive

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

Manager

• Assists the SM Study Lead and study team with the operational conduct of clinical studies (e.g., CTT minutes, clinical supplies planning/tracking, lab specimen tracking, imaging data reconciliation, status update reports, study closeout activities)
• May support a single study or multiple studies
• May lead a study with limited scope (e.g., Survival Follow-up)
• May be responsible for tracking study timelines and will be proficient in project management tools
• May interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical study objectives

Study Manager – Oncology

Clinical Research

• May lead or support a study or studies, depending on size/complexity.
• Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
• Responsible for trial design and endpoint development in collaboration with CD
• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports
• Sets up/supports SAC, DMC, adjudication committees
• Collaborates with medical writer, participates in governance committee review
• Reviews/updates informed consent
• Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)
• Monitors data issues requiring clinical input
• Prepares scientific slides, attends and presents protocol information at Investigator Meeting
• Scientific lead on Clinical Trial Team (CTT)
• Coordinates planning of lab, bio specimens and imaging specifications
• Co-authors newsletters with SM
• Participates in Database lock activities
• Collaboratively plans CSRs, CTDs/WMAs with medical writing
• Supports publications/presentations as needed
• Reconciles and review all protocol deviation classifications in SPECTRUM
• Assesses and prepares protocol deviation list for CSR
• Collaborates with medical writing to develop trial results communication for investigators
• Provides scientific assessment for Operational Reviews
• Supports SM/MW activities as needed to achieve CTT deliverables.
• Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)
• May act as mentor to other CSs

Senior Clinical Scientist – Oncology

• Assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management
• May support a single study or multiple studies
• May lead a study with limited scope (e.g., Survival Follow-up)
• May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives

Clinical Scientist – Oncology

Engineer

• Coordinate multiple validation activities with project teams, various departments, and external vendors to include: Installation Qualification (IQ); System Testing; Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control
• Conduct meetings for a GxP Risk Impact Assessment (RIA) and 21 CFR Part 11/Annex11 Assessment
• Assist in the creation of User Requirements Specification, Functional Requirements Specification, and Technical Design Specification
• Create all System Delivery Life Cycle (SDLC) deliverables that are authored by Senior Validation Engineer
• Review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Work Instructions (WIs)
• Create, review, and update SOPs and WIs associated with ICON’s SDLC
• Conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time
• Create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and regulations, such as 21 CFR Part 11, to ICON personnel
• Represent IT Validation during sponsor audits, inspections, and conducting external vendor audits. Focus on meeting project schedules, conduct SDLC and Validation training, and collect metrics

Senior Validation Engineer

Compliance

• Lead regulatory submissions that enable trials to start on time – Prepare and submit clinical trial applications, ethics committee submissions, and communications with regulatory authorities, ensuring every study begins with the highest standards of compliance and integrity.
• Coordinate across teams and stakeholders to unlock study progress – Liaise with internal colleagues and external partners to secure approvals and authorizations, keeping studies on track and supporting patient access to innovative treatments.
• Ensure transparency and accuracy in all regulatory records – Maintain comprehensive documentation of submissions, approvals, and correspondence so that study decisions are informed, traceable, and compliant with global and local regulations.
• Empower study teams with regulatory expertise – Provide guidance and support on study start-up requirements, helping colleagues navigate complex regulatory processes efficiently and effectively.
• Drive process improvements that accelerate research – Identify opportunities to optimize start-up workflows, enhancing efficiency and contributing to ICON’s culture of quality and innovation.

Study Start Up Associate II – Regulatory

• Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region.
• Assess current processes to ensure adherence to applicable regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with client standards.
• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the harmonization of processes across the regions.
• Liaise between the global functions, the affiliates and Business Partners (overall Territories: EU, Canada, Australia, US, Japan and Brazil, MENA, South Korea, China, Singapore)
• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the management of innovation projects for increasing Regional Team efficiency.
• Support the Regional PV Leads in the establishment and maintenance of the applicable pharmacovigilance system specific to the country/region
• Support the Regional PV Leads in the revision of documents pertinent to Regional PV tasks
• Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region.
• Contribute to the Pharmacovigilance System Master File (PSMF) data collection in any applicable country/region
• Contribute to increase the visibility of the GPS team/function throughout.
• Closely collaborate with other functions including regulatory, marketing, medical, communications, quality, legal, as well as other teams as needed.
• Develop relationships with cross functional teams as it relates to adverse event reporting and other pharmacovigilance activities.
• Maintain an in-depth knowledge of local regulations, expectations and regulatory authority contacts and perform activities related to the interpretation and review of existing and evolving safety requirements.
• Actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the Quality team.
• Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development.
• Contribute to the development and evaluation of Key Performance Indicators as related to pharmacovigilance as it relates to the assigned tasks.
• Drive Continuous Improvement initiatives as needed.
• May perform other tasks as appropriate.

Senior Regional Pharmacovigilance Manager

• Work with the Clinical Trials Information System (CTIS)
• Provide support for submissions and other documents by performing necessary tasks including assembly, dispatch among others and coordinating resources for submissions.
• Proactively identify and mitigate risks through CTIS helpdesks regarding data/document management and upload to CTIS and liaise with internal/external stakeholders to resolve
• Actively maintain applicable study-level account access for assigned projects for CTIS to maintain compliance and confidentiality
• Collaborate with key stakeholders to manage and perform data entry and document upload
• Monitor CTIS notifying applicable stakeholders of activities for their action and subsequent follow up
• Create files documenting submissions completed through CTIS, conclusions, decisions and any other communication provided via CTIS
• Perform Quality Control review in accordance with applicable process
• Maintain agreed timelines
• Ensure project-specific training is completed on time, as applicable

Regulatory Technician

Research Analyst

• Coordinate activities to set up and monitor a study
• Complete accurate study status reports and maintain study documentation
• Submission of protocol, consent documents for ethics/IRB approval
• Assist in preparing regulatory submissions as requested
• Participate in preparing and reviewing study documentation and feasibility studies for new proposals
• Balance sponsor generated queries efficiently and responsible for study cost-effectiveness
• Assist in training and mentoring less expert CRA's and/or lead CRA's working on international projects

Senior Clinical Research Associate

• Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA
• Provide regulatory guidance and efforts to internal teams
• Participate in agency interactions and regulatory submissions
• Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines
• Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

Regulatory Submissions 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

Senior Vendor Manager – 6 Months Assignment

Project Manager

• Responsible for the overall tactical and strategic direction and management of projects through designated project managers, ensuring consistency with corporate strategy, consistency of process across projects and internal and external customer satisfaction with the projects.
• Directs and provides day-to-day tactical oversight to their assigned Project Management team.
• Provides vision, leadership and mentorship to assigned team with respect to performance and career development.
• Accountable for the overall direction, coordination, implementation, execution, control and completion of all programs/projects, ensuring consistency with company strategy, commitments and goals.
• Accountable for compliance of the Project Management team with IMC and ICON policies and procedures.
• Ensure optimal planning, allocation and performance of resources within Project Management.

Senior Manager, Project Management – Imaging and Cardiac

• The Senior Project Manager is the main point of contact for customers on all assigned projects and acts as the lead on a portfolio of clinical trials within ICON Medical Imaging and Cardiac Safety Solutions team.
• Act as primary point of contact for customer communication, managing routine teleconferences and reporting deliverables.
• Responsible for developing project timelines, assure adherence to the timelines, and provide customer support throughout the life cycle of a project for all study-related activities within a clinical trial.
• Coordinate cross-functional activities of internal resources to ensure quality and on-time project deliverables are met.
• Responsible for maintaining the proper project documentation and ensuring compliance with SOPs and regulatory requirements for clinical trials.
• Responsible for revenue forecasting, tracking, and submittal, and will also update budgets and contracts as necessary.