10,000+ employees
Founded 1990
đź Consulting
đĽ Healthcare
đŚ 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.
đĽ 0 minutes ago
đ Canada, United States â Remote
â° Full Time
đ Senior
đ§Ş Clinical Research
đť Ghost score 10%
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10,000+ employees
Founded 1990
đź Consulting
đĽ Healthcare
đŚ 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 clinical studies depending on size and complexity ⢠Ensure clinical/scientific execution of protocols when serving as study lead ⢠Act as clinical point of contact for scientific issues for internal and external stakeholders ⢠Lead trial design and endpoint development with Clinical Development ⢠Lead Medical Monitoring activities, including Medical Monitoring Plan development and SAE report review ⢠Set up and support SAC, DMC, and adjudication committees ⢠Collaborate on protocols, amendments, governance reviews, and study-specific documents ⢠Author protocol clarification letters and review/update informed consent ⢠Provide scientific input for data management and monitor clinically relevant data issues ⢠Monitor central laboratory and external safety data ⢠Prepare and present protocol information at Investigator Meetings ⢠Serve as scientific lead on the Clinical Trial Team ⢠Coordinate randomization, laboratory, biospecimen, and imaging specifications ⢠Participate in database lock activities and collaboratively plan CSRs and CTDs/WMAs ⢠Support publications and presentations ⢠Review protocol deviation classifications and prepare deviation lists for CSRs ⢠Collaborate on trial results communications for investigators ⢠Provide scientific assessments for operational reviews ⢠Support study management and medical writing activities to achieve team deliverables ⢠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 ⢠Infectious Disease experience required ⢠HIV experience highly preferred ⢠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 ⢠Reasonable accommodations during the recruitment process
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