ICON plc
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Healthtech • Biotech • Pharmaceutical • Manufacturing
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.
Healthtech • Biotech • Pharmaceutical • Manufacturing
Monitor clinical study progress at investigative sites or remotely to ensure trials follow protocol, SOPs, ICH-GCP and regulatory requirements. Conduct site monitoring, source data verification, regulatory document review, and communicate with study teams to support data integrity and patient safety.
Healthtech • Biotech • Pharmaceutical • Manufacturing
Coordinate site activations and maintenance across studies; collect and review Critical Document Packages (CDPs); forecast activation dates; liaise with sites, sponsors, and internal stakeholders; ensure regulatory/IRB submissions and TMF quality; manage translations, CTAs/budgets support, escalate issues, and mentor team members while driving process improvements and KPI achievement.