Senior Clinical Scientist

About the role

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are currently seeking a Clinical Scientist to join our diverse and dynamic team.

Responsibilities

• 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.
• Create 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.
• 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.
• Provide insights to and facilitate data review process improvements by identifying redundant reports, implementing innovative data analysis processes and tools, and their continuous improvement.
• 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.
• Effective under high time pressure, while maintaining high quality standards.
• Ability to effectively prioritize tasks, and implement accordingly.
• High proficiency in English (written and spoken).

Qualifications

• No travel required.

Skills

• Expertise in oncology therapeutic area.
• Knowledge of GCP and drug development processes.
• Ability to work in a matrix environment.
• Strong communication and collaboration skills.
• Proficiency in data collection and reporting tools.
• Ability to manage multiple tasks simultaneously.
• High proficiency in English.

Benefits

At ICON, we offer a range of benefits to support your well-being and work-life balance. These include various annual leave entitlements, health insurance offerings, competitive retirement planning, a global Employee Assistance Programme, and more. Visit our careers site to learn more about the benefits we offer.