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Senior Clinical Scientist
ICON plcClinical Scientist designing and conducting clinical studies at ICON, a global healthcare organization. Collaborating with teams to develop innovative treatments and improve patient outcomes.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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
ATS Keywords
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Hard Skills & Tools
clinical trial protocolsclinical data reviewdata analysisregulatory documentspharmacovigilanceGood Clinical Practice (GCP)clinical data collectiondata capture toolsInterim AnalysisPhase 1b/2 clinical research
Soft Skills
collaborationflexibilityadaptabilityprioritizationinfluence without authoritytime managementcommunicationtrainingprocess improvementproblem-solving