Senior Clinical Scientist

ICON Strategic Solutions; France; À distance; EUR 60 000 - 100 000; Plein temps

Résumé du poste

Join a leading clinical research organization as a Senior Clinical Scientist, where you'll be instrumental in late-phase oncology development. This role involves creating high-quality clinical trial protocols, supporting pharmacovigilance activities, and ensuring regulatory compliance. With a focus on breast and lung cancer, you'll leverage your extensive experience to drive data review strategies and enhance clinical data collection processes. Enjoy a competitive salary and a range of benefits that prioritize your well-being and work-life balance in a diverse and inclusive environment.

Prestations

Annual Leave Entitlements

Health Insurance Options

Retirement Planning Options

Employee Assistance Programme

Life Assurance

Childcare Vouchers

Gym Discounts

Travel Passes

Health Assessments

Qualifications

• 8+ years of experience in clinical research, especially in oncology.
• Proficient in clinical data collection and reporting principles.

Responsabilités

• Develop and create clinical trial protocols adhering to scientific standards.
• Support regulatory activities and prepare for agency meetings.

Connaissances

Clinical Trial Protocol Development

Data Review and Analysis

Pharmacovigilance

Regulatory Affairs

EDC Systems Proficiency

Process Improvement

Formation

Advanced Degree in Life Sciences

Outils

Excel

EDC Systems

Description du poste

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

The Senior Clinical Scientist will support late-phase development in oncology, specifically for a global biotech company.

Responsibilities

• Contribute to the development and creation of clinical trial protocols, adhering to high scientific and clinical standards and applicable regulations. Assist in identifying, formulating, and implementing amendments to the clinical protocol in collaboration with the clinical lead.
• Create study-level documents, including clinical sections of regulatory documents such as Investigator’s Brochures, briefing books, safety updates, and submission dossiers. Review and write clinical trial documents for CTR activities and publications, if applicable.
• Support pharmacovigilance activities, including contributing to aggregate reports, patient narratives, and attending pharmacovigilance monitoring meetings.
• Assist in regulatory activities, such as preparing for meetings with regulatory agencies.
• Support and guide the development of data review strategies, ensuring consistent implementation of protocol deviations, eligibility criteria, study assessments, and other protocol aspects across countries and sites. This may include support for Case Report Form (CRF) development and data capture tool implementation.
• Perform high-quality clinical data reviews and identify insights through ongoing patient-level review and trend analysis, supporting interim analyses, database lock activities, and resolution of scientific and medical issues throughout the study lifecycle.

#LI-REMOTE

#LI-NR1

You are:

• An advanced degree in life sciences, healthcare, or a clinically relevant field.
• At least 8 years of experience for Senior Clinical Scientist; 5 years for Clinical Scientist.
• Experience supporting late-phase development in breast and lung cancer areas.
• Knowledgeable in all aspects of drug development, including medical data review.
• Solid understanding of clinical data collection and reporting principles; proficient with systems and tools such as EDC systems and Excel. Experience in process improvement and system enhancements is a plus.

What ICON can offer you:

Our success depends on our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options for you and your family
• Retirement planning options
• Global Employee Assistance Programme with TELUS Health
• Life assurance
• Optional benefits such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

Visit our careers website to learn more: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are core to our culture. We are committed to providing an accessible environment for all candidates and ensuring equal opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.