ICON plc

Recruitment

• Responsible for study and PRR campaign specific training; liaising with internal stakeholders where required
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People Clients and Performance.
• Expert knowledge of applicable ICON SOPs, ICH-GCP and applicable regulations
• Expert knowledge of applicable ICON systems
• Reporting on team and study PRR deliverables
• Lead the development of training materials to support PRR, ASN and/or call center operations (Specific to department)
• As needed provide oversight to more junior members of staff assigned to the study, this includes but not limited to delegation of tasks and ensuring accountability.
• Communicate performance indicators of the department: number of leads, number of calls made, conversion rates to telescreen and booking, screen fail rate etc.
• Ensure the integrity of the patient database(s) by performing quality control through automated reporting
• Create a culture of process improvement with a focus on streamlining processes, adding value to our business and meeting client needs
• Travel (approximately 20%) domestic and/or international and attendance at Bid Defense and Kick-off meetings as required.

Manager, Patient Recruitment

Clinical Research

• 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

Human Resources

• Managing and supporting HR activities, with a strong focus on employee relations, performance management, and talent development.
• Partnering with senior management to develop and implement HR strategies that support business objectives and foster a high-performing culture.
• Ensuring compliance with HR policies, employment laws, and industry regulations across the organization.
• Analyzing HR metrics and trends to drive strategic decision-making and identify areas for improvement.

HR Manager – 12 Month FTC

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

Backend Engineer

• 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

Clinical Python Developer

• Serve as lead biostatistician for multiple low to moderate complex studies.
• Provide input to statistical components of clinical studies (e.g. protocol, mock shells, SAP text, programmed deliverables)
• Develop statistical analysis plans and reporting specifications.
• Responsible for statistical aspects of CRF design and edit specifications.
• Perform statistical analyses and interprets results for simple to complex clinical studies.
• Review simple to complex randomization specifications and dummy randomization schemes.
• Participates in bid defense meetings.

Principal Biostatistician

• Assist senior biostatisticians in clinical study support, including study design, sample size calculations, patient randomization, data analysis, and results reporting.
• Support the statistical aspects of case report form design.
• Help in writing statistical analysis plans, defining derived data, and designing statistical tables and figures for clinical summary reports.
• Write data quality control specifications, utilize relevant computer languages and software.
• Develop and execute data manipulation and analysis programs.
• Assist in conducting statistical analyses and interpreting results.
• Prepare statistical summary reports and contribute to the statistical methods sections of integrated study reports.
• Review and document analysis and programming work for audit trail purposes.
• Contribute to project document standards and maintain project-specific biostatistics files.
• Collaborate effectively with ICON project team members, including data management, statistical programming, and clinical research personnel.
• Embrace ICON's values, culture of process improvement, and commitment to client needs.

Senior Biostatistician

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

• 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

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

• 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

Manager, Patient Recruitment

Clinical Scientist – Oncology

HR Manager – 12 Month FTC

Senior Clinical Data Science Lead

Clinical Python Developer

Principal Biostatistician

Senior Biostatistician

Senior Account Executive

Senior Statistical Programmer

Study Manager – Oncology

Senior Clinical Scientist – Oncology

Clinical Scientist – Oncology

Senior Validation Engineer

Regulatory Technician

Senior Clinical Research Associate