Senior Clinical Scientist

Job not on LinkedIn

🔥 16 hours ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

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.

📋 Description

• May lead or support a study or studies, depending on size/complexity • If lead, accountable for the clinical/scientific execution of the protocol • Serve as clinical point of contact for scientific issues and questions for internal and external stakeholders • Responsible for trial design and endpoint development in collaboration with CD • Lead the Medical Monitoring team, including development of the Medical Monitoring Plan and review of SAE reports • Set up and support SAC, DMC, and adjudication committees • Collaborate on protocols and amendments and participate in governance committee review • Author protocol clarification letters • Contribute to study-specific documents • Review and update informed consent • Provide scientific input to data management activities • Monitor data issues requiring clinical input • Monitor central lab reports and other external data for safety and critical values • Prepare scientific slides and present protocol information at Investigator Meetings • Serve as scientific lead on the Clinical Trial Team • Review specifications and initiate allocation requests and approval schedules • Coordinate planning of laboratory, biospecimen, and imaging specifications • Co-author newsletters with the Study Manager • 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 • Assess and prepare protocol deviation lists for CSRs • Collaborate with medical writing on trial results communications for investigators • Provide scientific assessments for Operational Reviews • Support Study Manager and Medical Writer activities as needed to achieve CTT deliverables • Provide clinical specifications to the Study Manager 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, must have 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 • Employment with ICON is contingent upon having the legal right to work in the country where the role is based

🏖️ 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