ICON plc

Clinical Research

• Manage day-to-day biostatistics activities
• Serve as lead biostatistician for programs of studies, submissions, or individual studies
• Oversee statistical activities that support ICON's interactions with clients and regulatory agencies
• Review and approve statistical methods sections of study protocols
• Prepare and approve research proposals and budgets
• Participate in bid defense meetings and make presentations at marketing meetings with prospective clients

Principal Biostatistician

Manager

• Your focus will be on leading study-level vendor set-up and readiness activities for assigned vendor categories and ensure vendor deliverables are established to support study start-up and key milestones.
• Provide technical expertise in one or more of the following areas: Central Lab, eCOA, Medical Imaging, ECG, Home Health Care, Patient Recruitment & Retention, Adjudication.
• Provide vendor management expertise to Clinical Study Team for study level vendor strategy and selection support, including defining vendor requirements and evaluating proposals in partnership with Procurement.
• Translate the protocol requirements into vendor-facing requirements and specifications, ensuring alignment of vendor deliverables with study timelines and milestones.
• Ensure vendor set-up documentation is controlled and filed appropriately (e.g. version control and required repository /eTMF filing of vendor-related documents, as applicable).
• Identify gaps and drive continuous improvement of tools, processes and reporting that strengthen and standardize the study team-vendor interface.

Vendor Manager

Analyst

• Developing and executing validation strategies and plans to ensure the accuracy and integrity of clinical trial data.
• Collaborating with cross-functional teams to identify validation requirements and address data quality issues.
• Overseeing the review and analysis of validation results to ensure compliance with regulatory standards and internal protocols.
• Providing strategic guidance on validation methodologies and improvements to enhance data reliability.
• Building and maintaining relationships with external partners and stakeholders to support validation efforts and drive best practices.

Senior Clinical Validation Analyst

Compliance

• Contributing to regulatory strategy development for clinical programmes, including plans for health authority interactions and submissions
• Preparing, reviewing, and coordinating regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions
• Interpreting and applying relevant regulations, guidelines, and precedents to support compliant study design and execution
• Collaborating with clinical, safety, CMC, and other cross-functional teams to ensure alignment of regulatory content and messaging
• Monitoring changes in the regulatory environment and providing guidance on potential impact to programmes and submissions
• Supporting regulatory interactions and meetings, including preparation of materials and documentation of outcomes

Regulatory Scientist

• Managing the planning, execution, and delivery of IRT projects, ensuring alignment with clinical trial requirements and regulatory standards
• Collaborating with cross-functional teams, including clinical operations and technology specialists, to define project scope, objectives, and deliverables
• Developing project plans, timelines, and budgets while monitoring progress to ensure successful project outcomes
• Facilitating communication and stakeholder engagement to ensure transparency and address any project-related issues promptly
• Staying current with industry trends and advancements in IRT technologies to drive innovation and improve project delivery

Clinical Research Project Manager

Recruitment

• Contribute to talent acquisition and recruitment activities, taking responsibility for your deliverables and working collaboratively
• Collaborate with hiring managers to understand talent needs and develop effective recruitment strategies tailored to specific roles
• Manage the end-to-end recruitment process, ensuring a seamless experience for candidates and hiring teams
• Utilize data-driven insights to evaluate recruitment metrics and identify areas for improvement in the hiring process
• Build and maintain strong relationships with internal stakeholders and external talent sources to enhance our talent pipeline
• Stay current with industry trends and best practices in talent acquisition to drive continuous improvement and innovation

Talent Acquisition Business Partner

Clinical Operations

• Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery.
• Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration.
• Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track.
• Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives.
• Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders.

Senior Manager, Clinical Operations

• Senior Local Operations Manager handling site aligned E2E partner communication across stakeholders throughout trial lifecycles
• Serve as the primary communication point for sites, facilitating client teamwork for issue resolution
• Ensure consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
• Collaborate with central study team and local stakeholders for final selection of sites
• Meet recruitment targets with high quality data on time and within study budget
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the trial
• Drive study compliance by maintaining and updating trial management systems
• Contribute to site level recruitment strategy and contingency planning
• Deliver competent vendor management at the country level to support the study
• Ensure high standards for study monitoring by conducting quality local trial team meetings

Clinical Trial Manager II

• Lead the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc)
• Drive assessment, selection, engagement, and management of appropriate vendors
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and client SOPs, for all products and services delivered for their designated studies
• Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate
• Actively partner to build relationships and collaborate with oncology aligned staff in other global functions
• Encourage others within matrix and line teams to seek alternative perspectives and develop solutions
• Lead / support the conduct of investigator meetings and other study related meetings

Global Study Manager

• Manage day-to-day project and program management activities, supporting your team to deliver quality outcomes.
• Developing and executing project plans, focusing on achieving project goals and objectives.
• Leading cross-functional teams to ensure the successful implementation of project activities.
• Collaborating with stakeholders to identify project requirements and define project scope.
• Mentoring and guiding team members, fostering a culture of excellence and continuous improvement.
• Driving the development of project documentation and reports to present findings to stakeholders in a clear and actionable manner.
• Staying abreast of industry trends and emerging technologies to integrate best practices into project management strategies.
• Contributing to organizational growth through effective project leadership and strategic planning.

• Strong ability to apply statistics in the analysis of clinical trials
• Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
• Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
• Demonstrated ability in presenting results and defending statistical findings, study design and analysis.
• Excellent oral and written English communication skills
• Authored a protocol, DRT/DMC charter, SAP, CSR, or Research Project Plan (RPP)
• Strong knowledge of current CDISC standards for ADaMs

Lead Biostatistician

• Focus on sourcing and hunting for talent
• Responsible for the successful sourcing of external candidates to support internal job requirements in the United States and Canada
• Develop external networks through web-based portals
• Fully utilize and maintain candidate databases and systems
• Works with the Talent Acquisition Business Partner’s to develop business and staffing requirements, recruitment strategies, and tactics
• Networking through technical journals, publications, social media and the internet
• Client mapping in order to network and build on an existing database
• Continuously sources applicants for potential openings; maintain a pipeline of qualified individuals
• Conducts screening interviews to identify qualified candidates
• Provides meaningful feedback and recommendations on candidates to the Client Facing Recruiters
• Identifies candidates for key positions, and develops the relationship required to effectively recruit for current or future positions
• Works with Talent Acquisition Business Partner’s to post open positions and publicize the role within social media forums, job boards, universities or other channels
• Engages with Hiring Managers to gain a better understanding of the recruiting needs

Talent Sourcing Recruiter – Contract

QA Engineer

• Plan, schedule, and conduct technology, data integrity, and process audits across internal functions and external vendors
• Develop risk-based audit plans, defining scope, audit approach, and regulatory alignment
• Conduct audits of AI/ML-enabled systems, including AI lifecycle and dataset governance
• Prepare clear, structured audit reports with actionable findings and recommendations
• Support regulatory inspections and client audits
• Review and assess validation deliverables
• Evaluate risk-based validation strategies aligning with industry standards
• Act as a Subject Matter Expert for Computer System Validation (CSV) and AI validation

Principal Auditor, Quality Assurance

• Oversee clinical trial management workstreams
• Ensure deliverables meet quality and timeline expectations
• Collaborate with cross-functional teams to design and implement effective clinical trial enrollment
• Develop and implement comprehensive clinical trial protocols
• Oversee and manage the day-to-day operations of clinical trials
• Ensure compliance with regulatory standards
• Analyze and interpret clinical trial data, identifying trends
• Provide insights to optimize study outcomes
• Proactively address challenges and implement effective solutions
• Communicate effectively with internal and external stakeholders

Research Analyst

• Acts as primary local company contact for assigned sites for specific trials.
• Develops meaningful site relationships through consistent collaborative communication and engagement.
• May participate in site feasibility and/or pre-trial site assessment visits
• Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
• Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
• Ensure site compliance with study protocol, ICH-GCP, and local/country regulations
• Ensure ongoing adequacy of site (facilities, staff) for trial conduct
• Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
• Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
• Ensures site non-IMP study supplies are adequate for trial conduct.
• Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
• Oversees the appropriate destruction of clinical supplies.
• Ensures site staff complete data entry and resolve queries within expected timelines.
• Ensures validity and completeness of data collected at trial sites
• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
• Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
• Fully documents trial related activities, in particular monitoring.
• Writes visit reports and follow-up letter in accordance with the SOPs.
• Promptly communicates relevant status information and issues to appropriate stakeholders.
• Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
• Aligns with relevant training requirements.
• Act as local expert in assigned protocols.
• Develops therapeutic knowledge sufficient to support role and responsibilities.
• Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
• Prepares trial sites for close out, conduct final close out visit.
• Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
• May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.

Principal Biostatistician

Vendor Manager

Senior Clinical Validation Analyst

Regulatory Scientist

Clinical Research Project Manager

Talent Acquisition Business Partner

Senior Manager, Clinical Operations

Clinical Trial Manager II

Global Study Manager

Global Study Manager

Lead Biostatistician

Talent Sourcing Recruiter – Contract

Principal Auditor, Quality Assurance

Global Study Manager

Clinical Research Associate II