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Senior Clinical Scientist

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đŸ”„ 1 minute ago

🌐 United States, Canada – Remote

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🔔 Pennsylvania – Remote

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⏰ Full Time

🟠 Senior

đŸ§Ș Clinical Research

đŸ‘» Ghost score 10%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

đŸ’Œ Consulting

đŸ„ 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.

📋 Description

‱ May lead or support one or more studies depending on size and complexity ‱ Accountable for clinical/scientific execution of the protocol when serving as lead ‱ Serve as clinical point of contact for scientific issues and questions for internal and external stakeholders ‱ Support trial design and endpoint development in collaboration 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 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 for data management activities and monitor clinical data issues ‱ Monitor central laboratory reports and other external safety data ‱ Prepare scientific slides and present protocol information at Investigator Meetings ‱ Serve as scientific lead on the Clinical Trial Team ‱ Coordinate laboratory, biospecimen, and imaging specifications ‱ Participate in database lock activities ‱ Collaboratively plan CSRs and CTDs/WMAs with medical writing ‱ Support publications and presentations as needed ‱ Reconcile and review protocol deviation classifications in CTMS ‱ Prepare protocol deviation lists for CSR ‱ Collaborate on trial results communications for investigators ‱ Provide scientific assessment for operational reviews ‱ Support Study Manager and Medical Writer activities to achieve Clinical Trial Team deliverables ‱ Provide clinical specifications for interactions with external vendors ‱ May mentor other Clinical Scientists

🎯 Requirements

‱ 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

đŸ–ïž Benefits

‱ 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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