Senior Clinical Scientist

Pharmaceutical Research Associates, Inc; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

Join a leading clinical research organization as a Senior Clinical Scientist, where your expertise will contribute to high-quality clinical trials. In this role, you will develop protocols, support pharmacovigilance, and ensure compliance with regulatory standards. This innovative firm values diversity and offers a competitive salary alongside benefits that promote well-being and work-life balance. If you are passionate about improving patient outcomes and thrive in a collaborative environment, this is the perfect opportunity for you to make a significant impact in the field of clinical research.

Benefits

Annual Leave Entitlements

Health Insurance Options

Retirement Planning Options

Global Employee Assistance Programme

Life Assurance

Flexible Benefits (Childcare Vouchers, Gym Memberships)

Travel Passes

Health Assessments

Qualifications

• 8+ years of experience in clinical research or 5+ for Clinical Scientist roles.
• Familiarity with drug development processes, especially in Oncology.

Responsibilities

• Develop clinical trial protocols and regulatory documents.
• Support pharmacovigilance activities and regulatory meetings.

Skills

Clinical Trial Protocol Development

Pharmacovigilance

Clinical Data Review

Good Clinical Practice (GCP)

Regulatory Documentation

Data Analysis

Multitasking under Pressure

Effective Communication

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.

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. Assist in the identification, formulation, and implementation of 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.
• Produce training materials, share best practices, and provide training to clinical trial teams.
• Support preparation and participate in study-level meetings, including Investigator Meetings, Data Monitoring Committees, and others.
• Develop data review strategies, ensuring consistent implementation of protocol deviations, eligibility criteria, and study assessments across sites and countries. Support CRF development and data capture tool implementation.
• Perform high-quality clinical data reviews and identify insights through patient-level review and trend analysis, supporting interim analyses, database activities, and resolution of scientific issues throughout the study lifecycle.
• Enhance review quality with an emphasis on subject safety, data integrity, and trend identification. Facilitate process improvements in data review and analysis.
• Collaborate closely with the clinical development lead and ensure all medical oversight questions are addressed appropriately.

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 roles.
• Familiar with Good Clinical Practice (GCP) and drug development processes, ideally in Phase 1-3 trials, preferably in Oncology or Immuno-Oncology.
• Experienced in setting up, organizing, and executing global clinical studies within pharmaceutical companies, CROs, or academic research institutions.
• Knowledgeable in clinical data collection and reporting systems (e.g., EDC systems, Excel), with a track record of process improvement and system enhancement.
• Capable of working effectively in a matrix environment and influencing without authority.
• Flexible, adaptable, and able to multitask under high pressure while maintaining quality standards.
• Proficient in English (written and spoken).

What ICON offers

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
• Retirement planning options
• Global Employee Assistance Programme (TELUS Health)
• Life assurance
• Flexible benefits like childcare vouchers, gym memberships, travel passes, and health assessments

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

At ICON, inclusion and belonging are fundamental. We are committed to providing an accessible environment for all candidates and a workplace free of discrimination. If you need accommodations during the application process, please let us know through the provided form: https://careers.iconplc.com/reasonable-accommodations

We encourage you to apply even if you’re unsure whether you meet all requirements. You might be the right fit for this or other roles at ICON.