10,000+ employees
Founded 1990
💼 Consulting
🏥 Healthcare
📦 Logistics
Consulting • Healthcare • Logistics
ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.
🔥 2 minutes ago
🌐 United States, Canada – Remote
🔔 Pennsylvania – Remote
⏰ Full Time
🟠 Senior
🧪 Clinical Research
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10,000+ employees
Founded 1990
💼 Consulting
🏥 Healthcare
📦 Logistics
Consulting • Healthcare • Logistics
ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.
• Lead or support studies depending on size and complexity • Serve as clinical point of contact for scientific issues and questions for internal and external stakeholders • Lead trial design and endpoint development in collaboration with the Clinical Director • Lead the Medical Monitoring team, including Medical Monitoring Plan development and SAE report review • Set up and support SAC, DMC, and adjudication committees • Collaborate on protocols and amendments and participate in governance committee review • Author protocol clarification letters and contribute to study-specific documents • Review and update informed consent materials • Provide scientific input to study management for data management activities • Monitor data issues, central laboratory reports, and external safety data • Prepare scientific slides and present protocol information at Investigator Meetings • Serve as scientific lead on the Clinical Trial Team • Review specifications and initiate allocation and randomization requests • Coordinate laboratory, biospecimen, and imaging specifications • Co-author newsletters and participate in database lock activities • Collaboratively plan CSRs and CTDs/WMAs with medical writing • Support publications and presentations • Reconcile and review protocol deviation classifications and prepare protocol deviation lists for CSRs • Collaborate with medical writing on trial results communications • Provide scientific assessments for Operational Reviews • Support study management and medical writing activities to achieve Clinical Trial Team deliverables • Provide clinical specifications for external vendor interactions • Mentor other Clinical Scientists as needed
• BS/BA in Life Sciences with 7+ yrs clinical research experience • MS/PhD in Life Sciences with 5+ years clinical research experience • If no degree in Life Sciences, significant experience in clinical development (>11 years) • Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead CS required • Medical monitoring experience required • Oncology experience required • Excellent Excel and PP skills required • Excellent written and oral communication skills • Ability to travel up to 15% (might include international travel) • Legally authorized to work in Canada or the US • Must not require, now or in the future, sponsorship for employment visa status
• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways
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