Jobs at ICON plc

Leads operational delivery of clinical trials from study start-up through closeout, managing timelines, budgets, vendors, sites, monitoring, quality, compliance, risk mitigation, and cross-functional stakeholders. Oversees enrollment, study execution, performance metrics, and database lock while supporting CRAs and ensuring adherence to protocols, ICH-GCP, and regulatory requirements.

Oversee clinical trial monitoring for cardiovascular and respiratory studies in Quebec. Ensure site adherence to protocols, regulations, and GCP standards; conduct site visits; resolve issues; support data collection and reporting; train site staff and CRAs; and maintain stakeholder relationships. The role requires managing multiple sites and projects independently, ensuring data integrity, and traveling approximately 60% of the time.

Oversee clinical trial monitoring for cardiovascular and respiratory studies, 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 site personnel and other CRAs, manage multiple sites and projects, and maintain stakeholder relationships. The role requires approximately 60% travel.

Manages country-level clinical trial operations, regulatory submissions, budgets, contracts, payments, vendors, site readiness, timelines, and compliance. Coordinates with clinical, finance, legal, regulatory, pharmacovigilance, vendors, sites, ethics committees, and regulatory authorities. Develops local-language materials, oversees study supplies and filings, manages risks, and supports process improvement, training, mentoring, and country-specific trial delivery.

Monitors clinical studies at investigative sites or remotely, ensuring trials are conducted, documented, and reported according to protocols, SOPs, ICH-GCP, and regulatory requirements. Requires a scientific or healthcare degree, clinical monitoring experience, knowledge of applicable regulations, French and English fluency, and willingness to travel 70%. Oncology monitoring experience is preferred.

Monitor clinical studies on-site or remotely to ensure trials follow protocol, SOPs, ICH-GCP and regulations. Requires frequent travel (70%), bilingual English/French, relevant degree or clinical background, and clinical monitoring experience (level-dependent). Oncology monitoring experience preferred. Must be authorized to work in the US or Canada without sponsorship.

Lead global portfolio-level resource demand and capacity planning for clinical delivery groups. Own forecasting, challenge resource requests, optimize utilisation and bench management, lead and develop the resource management team, partner cross-functionally (Finance, PM, TA, Sales), advance forecasting tools and governance, ensure compliance with ICH-GCP and quality standards, and provide strategic guidance to protect delivery quality and margin.

Coordinate clinical trial administration, document management, regulatory/site start-up, budgeting/contracts/payments, clinical supply and labeling, and meeting planning. Update CTMS/eTMF, prepare submission packages, manage site finances and contracts, and support investigator communications to ensure study compliance and timely start-up.

Lead the development, validation, and maintenance of clinical data programming solutions for EDC/CDMS systems, vendor data, analytics, reports, integrations, and data transfers. Provide technical leadership across studies, serve as a programming subject matter expert, mentor programmers, support study teams, and drive automation and process improvements. Collaborate with data managers, biostatisticians, and project managers to ensure high-quality clinical trial data management solutions.

Leads clinical data science project teams responsible for setting up, maintaining, controlling, and closing clinical trial systems. Reviews technical documentation and CRFs, supports bids and kickoffs, manages customer and vendor interactions, oversees system integrations and UAT, tracks timelines, budgets, resources, and revenue forecasts, and escalates project risks. Requires 5+ years of clinical data management experience, clinical systems expertise, project management skills, and fluent English plus the host-country language.

Facilitates clinical trial site activation by preparing regulatory and ethics submissions, coordinating approvals, maintaining submission records, supporting study document development, and contributing to start-up meetings. The role requires collaboration with internal and external stakeholders, strong organization, attention to detail, and the ability to manage multiple tasks independently in a fast-paced environment.

Develops, validates, and maintains clinical data programming solutions for CDMS and clinical trials, including eCRFs, edit checks, data validation outputs, reports, extracts, transfers, and vendor data programs. Collaborates with cross-functional clinical data teams, supports study setup and maintenance, mentors junior programmers, creates training materials, and improves technical systems and processes.

Leads the design, development, review, and implementation of clinical systems for clinical trials. Designs CRFs, edit checks, dynamic checks, and database specifications; performs quality reviews; manages post-production database changes; supports timelines, change management, and study decision-making. Requires clinical research systems experience, CDMS expertise, protocol interpretation, and knowledge of platforms such as Medidata Rave or Veeva EDC. The role is remote in Canada with approximately 10% domestic or international travel.

Oversee and monitor clinical trial sites to ensure GCP and protocol compliance, conduct site visits, resolve issues, ensure data integrity, train site staff and CRAs, collaborate with cross-functional teams, and maintain stakeholder relationships to support trial execution.

As a Global Study Manager, you will lead projects, manage cross-functional teams, and ensure successful project execution while mentoring team members.