Senior Clinical Scientist

Senior Clinical Scientist

ICON

Remote, Multiple Countrie

Senior Clinical Scientist will support late phase development in oncology area, this role is dedicated to a global biotech company.

Responsibilities:

• Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations. Also 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 (if applicable).
• Support pharmacovigilance activities (e.g. contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings).
• Support regulatory activities, like preparation of meetings with regulatory agencies.
• Supports and guides 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). This could also include support for Case Report Form (CRF) development, and implementation of data capture tools.
• Perform high quality clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle.

You are:

• Advanced degree in life sciences/healthcare or clinically relevant degree.
• 8+ years for Sr. Clinical Scientist; 5+ years for Clinical Scientist.
• Experience as a clinical scientist support late phase development in the areas of breast and lung cancer.
• Knowledgable in all aspects of drug development including medical data review.
• Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Ideally first experiences in how to improve and accelerate processes, systems and tools and drive continuous improvement.

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