Clinical Scientist

Role Summary

Clinical Scientist is a key member of the Medical Team providing scientific support for late-stage clinical studies. The role involves close collaboration with the Clinical Research Director (CRD) and other Study Team members to ensure quality medical and scientific contributions across study activities from setup to clinical study report, while complying with quality and regulatory processes.

Responsibilities

• Contributes to preparation and/or review of documents requiring a scientific background (protocols, patient information, presentations, study reports, charters, registrations, lay summaries, etc.).
• Supports CRD in preparing medical answers to questions from Health Authorities, IRBs/Ethics Committees, investigators, and experts.
• Assists in defining critical data/processes, risks, quality tolerance limits, and contributes to the study risk management plan.
• Updates study documents and ensures adequacy of eCRFs with protocols/amendments; rationalizes data collection needs.
• Develops study-specific training material and participates in Investigator, Study Team, and monitoring team training on medical information.
• Contributes to centralized monitoring strategy development, data validation, and review processes; supports CRD in safety case reviews and anticipates/addresses last-minute queries.
• Supports CRD in organizing and conducting Steering Committees, Data Monitoring Committees, and Adjudication Committee meetings.
• Supports regulatory documents filing and archiving.
• Reviews study plans, reports, and publications for accuracy with the clinical study report and ensures completeness of study report appendices under CRD responsibility.

Qualifications

• Fellowship certificate of completion of Howard program in Spring 2026
• Scientific expertise or strong interest with ability to learn in the assigned study/project domain
• Leadership to direct and organize activities on behalf of the CRD
• Quality-focused with a data-driven, risk management mindset
• Familiarity with digital tools and data analytics
• Ability to handle multiple tasks, work autonomously, provide status updates, and escalate issues when needed
• Strong synthesis, presentation, and communication skills (verbal and written)
• Team- and results-oriented
• Experience working internationally with strong English skills (verbal and written if English is not native)

Skills

• Scientific writing and document review
• Medical/clinical data interpretation and risk assessment
• Communication and collaboration across cross-functional teams
• Regulatory understanding and documentation practices
• Training material development

Education

• Fellowship certificate of completion of Howard program in Spring 2026