ICON plc
Teams at ICON plc
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Healthtech • Biotech • Pharmaceutical • Manufacturing
Coordinate clinical trial site start-up activities including IRB submissions, ICF customization and regulatory document collection. Manage multiple site documents across studies, track approvals in CTMS/eTMF, support enrollment and closeout, ensure ICH/GCP and regulatory compliance, and communicate status to stakeholders.
Healthtech • Biotech • Pharmaceutical • Manufacturing
Lead clinical trial monitoring to ensure protocol, regulatory and GCP compliance. Conduct site visits, resolve issues, support data integrity, train site staff and CRAs, and collaborate with cross-functional teams while managing multiple sites.
Healthtech • Biotech • Pharmaceutical • Manufacturing
Lead and oversee end-to-end clinical trial start-up activities including site identification, feasibility, regulatory submissions, and activation. Manage and mentor a study start-up team, coordinate with sponsors and internal stakeholders, monitor timelines and budgets, mitigate risks, and drive process improvements to ensure timely, compliant trial initiation.