Jobs at ICON plc

Oversee clinical trial monitoring activities, ensuring site adherence to protocols, regulatory requirements, and GCP standards. Conduct site visits, assess performance, resolve issues, support data integrity, and collaborate with cross-functional teams. Train and guide site staff and other CRAs, manage stakeholder relationships, and contribute to continuous quality improvement. The role requires independent management of multiple sites and approximately 60% travel.

Monitors medical device clinical trials at research sites, verifying subject safety, source data accuracy, informed consent, regulatory documentation, device accountability, and protocol compliance. Supports study start-up, enrollment, follow-up, and closeout through onsite and remote monitoring. Trains site personnel, investigates discrepancies and reportable events, documents findings, escalates noncompliance, supports inspections, and collaborates with study teams and sites. Requires medical device and site monitoring experience, relevant therapeutic expertise, and up to 60% travel.

Leads the strategic and tactical management of an Imaging Project Management team within clinical research. Responsibilities include supervising project managers and assistants, allocating resources, managing workloads and forecasts, developing performance metrics, resolving escalations, improving processes, overseeing training and compliance, supporting recruitment, managing financial performance, and leading risk and contingency planning. Requires up to 25% travel.

Manage feasibility and site activation activities for clinical studies, including project plans, timelines, site recommendations, regulatory and ethics submissions, essential documents, contracts, and activation milestones. Coordinate cross-functional and sponsor stakeholders, track KPIs, mitigate risks, resolve study issues, support audits and inspections, and ensure quality, budget, and timeline compliance. The role also includes mentoring, process improvement, business development support, and approximately 10% domestic or international travel.

Conduct clinical sample testing and data analysis in a CLIA/CAP-accredited laboratory. Develop, optimize, and validate clinical NGS assays; perform nucleic acid isolation, QC, library preparation, and result reporting. Author SOPs, validation plans, reports, and workbooks, and present technical findings to internal teams and clients. The role requires molecular biology expertise and experience with NGS, with oncology, genetics, infectious disease, automation, bioinformatics, or IVD assay development experience advantageous.

Manages clinical trial vendors, sites, timelines, budgets, study materials, monitoring deliverables, eTMF compliance, risk management, audits, inspections, trial registry updates, and cross-functional study processes. Builds vendor and site relationships, supports site readiness and financial oversight, ensures regulatory compliance, and mentors junior colleagues. The role requires hybrid office attendance in Warren, NJ, Armonk, NY, or Cambridge, MA.

Lead feasibility informatics strategy for clinical trial proposals and awarded feasibility projects. Provide data-driven feasibility analyses using internal/external data, support bid defenses, manage delivery and handover to site identification, assess risks, and collaborate with cross-functional teams to meet sponsor objectives.

Lead monitoring activities for Phase I oncology clinical trials, ensure GCP/regulatory compliance, conduct site visits, train and guide site staff and other CRAs, manage multiple sites, collaborate with cross-functional teams, and maintain data integrity while traveling to sites (~60%).

Oversee and monitor clinical trial sites to ensure GCP and protocol compliance, conduct site visits, resolve issues, support data collection and reporting, train site staff and CRAs, and maintain stakeholder relationships for successful trial execution.

Provide operational support for clinical trials including reporting, meeting coordination, document and TMF management, site tracking, vendor oversight, training materials, registry postings, and process improvement to support study leads and ensure trial readiness and close-out.

Lead and conduct clinical trial monitoring for oncology studies, ensuring GCP and protocol compliance. Manage multiple sites, perform site visits, resolve issues, support data integrity and reporting, train site staff and mentor other CRAs, and collaborate with cross-functional teams to maintain trial quality.

Support clinical study operations: prepare reports and meeting materials, manage TMF/CTMS/SharePoint, assist document reviews (ICF/CRFs), track site activation/enrolment and monitoring, support registry postings and vendor oversight, and help with study close-out activities and SOP initiatives.

Oversee clinical trial monitoring for sponsor-dedicated oncology studies, ensuring site adherence to protocols, regulations, and GCP standards. Conduct site visits, resolve performance issues, support data integrity, train site staff and CRAs, and collaborate with cross-functional stakeholders. Manage multiple sites and projects independently while maintaining strong relationships and driving compliance. The role requires approximately 60% travel.

Program and manage real-world healthcare datasets from claims and EMR sources. Clean, transform, normalize, and prepare analysis-ready data; create data dictionaries and programming documentation; build dashboards; and support research teams with analytics and programming for real-world evidence generation.

Manages multiple healthcare improvement initiatives across timelines, budgets, workstreams, risks, deliverables, and stakeholder relationships. Coordinates Medical Affairs, Legal, compliance, health systems, professional societies, research institutes, and other partners. Tracks spending and milestones, supports governance meetings, synthesizes performance data, maintains project dashboards and collaboration tools, conducts landscape analyses, and identifies process improvements. Requires healthcare systems knowledge, quality improvement exposure, and CRO or pharma project management experience.

Leads clinical outcome assessment (COA) research programs, including PRO, ClinRO, PerfO, and ObsRO development and validation. Designs qualitative and psychometric research, supports clinical trial protocols and statistical plans, prepares regulatory documents, develops COA strategies, and publishes findings. Requires collaboration with cross-functional teams, regulators, patients, caregivers, payers, and external partners across multiple therapeutic areas.

Manage and monitor clinical trial sites including qualification, initiation, monitoring, and close-out visits. Ensure protocol compliance, data integrity, patient safety, query resolution, and contribute to study documentation and reports.

Leads clinical data science project teams supporting the setup, maintenance, integration, quality control, and closure of clinical trial systems. The role involves client and vendor coordination, technical documentation review, CRF quality review, timeline and budget tracking, system integration oversight, sales support, and internal user acceptance testing. Candidates need clinical data management experience, relational database knowledge, data flow diagramming skills, project management capabilities, protocol interpretation expertise, strong communication skills, and a bachelor's degree.

Coordinate and execute sponsor contracts and change orders for early-phase clinical research projects. Responsibilities include reviewing contractual terms, budgets, payment schedules, and project documents; collaborating with legal, sales, finance, operations, and project teams; analyzing financial implications; maintaining Salesforce records and contract files; supporting client negotiations; and managing multiple deadlines while ensuring accurate quality-control submissions.

Oversee clinical trial sites and ensure protocol, regulatory, and GCP compliance. Conduct site visits, assess performance, resolve issues, support site staff, and maintain data integrity and participant safety. Collaborate with cross-functional teams on data collection and reporting, train site personnel and CRAs, and manage relationships with stakeholders. The role requires extensive CRA experience, advanced relevant education, strong monitoring and organizational skills, and travel of at least 60%.