Senior Clinical Scientist

Clinical Scientist

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are currently seeking a Clinical Scientist to join our diverse and dynamic team. As a Clinical Scientist at ICON, you will play a critical role in designing and conducting clinical studies that advance our understanding of new therapies. You will contribute to the development of innovative treatments by applying scientific expertise and collaborating with multidisciplinary teams throughout the research process.

What You Will Be Doing:

• 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.

Your Profile:

• 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)
• Home Based
• No travel

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and com