Senior Clinical Scientist

Pharmaceutical Research Associates, Inc; United Kingdom; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player in clinical research is seeking a Senior Clinical Scientist to support late-phase development in oncology. This role involves creating clinical trial protocols, conducting data reviews, and assisting with regulatory submissions. The ideal candidate will have extensive experience in drug development and a strong background in clinical data management. Join a dynamic team that values diversity and offers a comprehensive benefits package focused on well-being and work-life balance. This is an excellent opportunity to contribute to impactful research in a supportive environment.

Benefits

Health Insurance Options

Retirement Planning Options

Global Employee Assistance Programme

Life Assurance

Flexible Benefits

Gym Discounts

Childcare Vouchers

Travel Passes

Health Assessments

Qualifications

• 8+ years of experience in clinical research, focusing on oncology.
• Knowledgeable in drug development and clinical data collection.

Responsibilities

• Develop and create clinical trial protocols adhering to regulations.
• Conduct high-quality clinical data reviews and support regulatory activities.

Skills

Clinical Trial Protocol Development

Pharmacovigilance

Clinical Data Review

Regulatory Submissions

EDC Systems

Excel

Education

Advanced Degree in Life Sciences

Tools

EDC Systems

Excel

Job description

Overview

As a Senior Clinical Scientist, you will join the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence. This role supports late-phase development in the oncology area and is dedicated to a global biotech company.

Responsibilities

• Contribute to the development and creation of clinical trial protocols, following 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 key 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-level deviations, eligibility criteria, study assessments, and other aspects across countries and sites. This may include supporting CRF development and data capture tools.
• Perform high-quality clinical data reviews and identify insights through ongoing patient-level review and trend analysis, supporting interim analyses, database activities, post-lock activities, and resolving scientific and medical issues throughout the study lifecycle.

Qualifications

You are:

• Holding an advanced degree in life sciences, healthcare, or a clinically relevant field.
• Having 8+ years of experience for Senior Clinical Scientist or 5+ years for Clinical Scientist.
• Experienced in supporting late-phase development in breast and lung cancer.
• Knowledgeable in all aspects of drug development, including medical data review.
• Familiar with principles of clinical data collection and reporting, and proficient in systems and tools such as EDC systems and Excel, with a focus on process improvement and system enhancement.

What ICON Can Offer You

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme with TELUS Health
• Life assurance
• Flexible, country-specific benefits such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

Visit our careers website to learn more about working at ICON.

At ICON, inclusion and belonging are fundamental to our culture. We are committed to providing an inclusive, accessible environment free of discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.