Senior Clinical Scientist
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
As a Senior Clinical Scientist at ICON, you will design and conduct clinical studies that evaluate the safety and efficacy of innovative treatments.
What You Will Do:
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.
Qualifications
Advanced degree in life sciences/ healthcare or clinically relevant degree.
Minimum 5+ years' experience as a Clinical Scientist
Oncology experience is a big plus
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
Home Based
No travel
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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 maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
