Senior Clinical Scientist

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🔥 8 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations • Contribute to the identification, formulation and implementation of amendments to the clinical protocol, in close collaboration with clinical lead • Contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers • Contribute to the review and writing of clinical trial documents for CTR activities, and publications (as applicable) • Support pharmacovigilance activities (e.g. contributing to creation and review of aggregate reports, patient narratives and attendance of pharmacovigilance monitoring meetings) • Support regulatory activities (preparation of meetings with regulatory agencies) • Produce training materials, share best practices and provide training to the broader clinical trial teams • Support preparation and (if applicable) participate in study level meetings (i.e. - Investigator Meetings, Data Monitoring meetings, and others) • Support and guide the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites) • Includes support for Case Report Form (CRF) development, and implementation of data capture tools • Deep expertise to perform in depth and high-quality clinical data review, to identify clinical data insights through ongoing patient level review and trends analysis to support Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle • Work to improve the quality of reviews and insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review • Provide insights to and facilitate data review process improvements by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement • For all these tasks, work in close collaboration and alignment with clinical development lead • Ensure all questions / issues requiring medical oversight are brought to the attention of the clinical development lead

🎯 Requirements

• Advanced degree in life sciences/ healthcare or clinically relevant degree • Minimum 8+ years' experience as a Clinical Scientist Oncology therapeutic area expertise required, preferably in Phase 1b/2 clinical research environment • Strong working knowledge of Good Clinical Practice (GCP) and drug development processes • Preferred knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO) environment • Sound knowledge of principles of clinical data collection and reporting with a demonstrated ability to use typical systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting • Demonstrated knowledge to drive continuous improvement of processes, systems and tools • Experience to work in a matrix, with high level of ability to informally influence and collaborate without authority • High flexibility and adaptive working style, ability to work on several tasks at the same time • Ability to work effectively under high time pressure, while maintaining high quality standards • Ability to effectively prioritize tasks, and implement accordingly • High proficiency in English (written and spoken)

🏖️ 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