10,000+ employees
Founded 1990
đŒ Consulting
đ„ Healthcare
đŠ Logistics
Consulting âą Healthcare âą 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.
đ„ 1 minute ago
đ United States, Canada â Remote
đ Pennsylvania â Remote
â° Full Time
đ Senior
đ§Ș Clinical Research
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10,000+ employees
Founded 1990
đŒ Consulting
đ„ Healthcare
đŠ Logistics
Consulting âą Healthcare âą 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.
âą May lead or support one or more studies depending on size and complexity âą Accountable for clinical/scientific execution of the protocol when serving as lead âą Serve as clinical point of contact for scientific issues and questions for internal and external stakeholders âą Support trial design and endpoint development in collaboration with Clinical Development âą Lead Medical Monitoring activities, including Medical Monitoring Plan development and SAE report review âą Set up and support SAC, DMC, and adjudication committees âą Collaborate on protocols and amendments and participate in governance committee review âą Author protocol clarification letters and contribute to study-specific documents âą Review and update informed consent materials âą Provide scientific input for data management activities and monitor clinical data issues âą Monitor central laboratory reports and other external safety data âą Prepare scientific slides and present protocol information at Investigator Meetings âą Serve as scientific lead on the Clinical Trial Team âą Coordinate laboratory, biospecimen, and imaging specifications âą Participate in database lock activities âą Collaboratively plan CSRs and CTDs/WMAs with medical writing âą Support publications and presentations as needed âą Reconcile and review protocol deviation classifications in CTMS âą Prepare protocol deviation lists for CSR âą Collaborate on trial results communications for investigators âą Provide scientific assessment for operational reviews âą Support Study Manager and Medical Writer activities to achieve Clinical Trial Team deliverables âą Provide clinical specifications for interactions with external vendors âą May mentor other Clinical Scientists
âą BS/BA in Life Sciences with 7+ yrs clinical research experience âą MS/PhD in Life Sciences with 5+ years clinical research experience âą If no degree in Life Sciences, significant experience in clinical development (>11 years) âą Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead CS required âą Medical monitoring experience required âą Oncology experience required âą Excellent Excel and PP skills required âą Excellent written and oral communication skills âą Ability to travel up to 15% (might include international travel) âą Legally authorized to work in Canada or the US âą Must not require, now or in the future, sponsorship for employment visa status
âą Competitive base salary and performance related incentives âą Health and wellbeing programmes including medical, dental, and vision coverage where applicable âą Retirement and pension plans âą Life assurance and disability coverage âą Employee assistance programmes and wellbeing resources âą Learning and development opportunities through structured training and career pathways
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