Senior Clinical Scientist

Overview

As a Senior Clinical Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• 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.
• 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 for example Investigator
• Meetings, Data Monitoring meetings, and others.
• 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.
• Work to improve the quality of reviews/ 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, for example 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.

 

 

Qualifications

You are:

 

• Advanced degree in life sciences/ healthcare or clinically relevant degree.
• 8+ years for Sr. Clinical Scientist; 5+ years for Clinical Scientist
• Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally
• Phase 1 – 3; ideally paired with experience in Oncology / Immuno-Oncology
• Good knowledge  of  set-up,  organization  and  execution  of  global  clinical  studies  in  a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution.
• 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.
• Experience to work in a matrix, ability to influence 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

 

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead