Remote Principal Research Scientist, Clinical Development

Syneos Health, Inc.; North Carolina; Remote; USD 80,000 - 140,000; Full time

Job summary

Syneos Health is seeking a Principal Research Scientist ONC - Clinical Development Scientist for sponsor-dedicated or remote US work. The role focuses on coordinating the development and validation of bioanalytical methods within client timelines, partnering across study design and regulatory submission teams.

Responsibilities include protocol development, CRF/Data Plan contributions, and support for regulatory submissions, with emphasis on GCP compliance and scientific problem solving.

Qualifications

• PharmD or PhD with 3+ years in clinical research or clinical pharmacology in biopharma or related fields.
• MS with 6+ years relevant scientific experience.
• BS or RN with 8+ years relevant scientific and/or drug development experience.
• Experience in Multiple Myeloma and/or CAR-T Therapy preferred.
• Proficiency with Microsoft Word and Excel and analytical software (e.g., Analyst).
• English bilingual communication (verbal and written).

Responsibilities

• Develops a solid understanding of clinical trial design and applies this knowledge to support the creation of study concept documents and clinical protocols.
• Participates in protocol review meetings, contributing to discussions on scientific rationale and operational study design considerations.
• Assists in the preparation of study protocols, protocol amendments, investigator meeting materials, study manuals, and other clinical trial documentation under guidance.
• Contributes to the development of Case Report Forms (CRFs), Data Management Plans, and Statistical Analysis Plans with supervision.
• Supports responses to investigator inquiries related to scientific, clinical, and procedural aspects of studies.
• Assists in the preparation and review of data outputs, summary reports, study findings, manuscripts, and scientific presentations.
• Provides support in the development and review of regulatory submission documents.
• Ensures compliance with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and SOPs.

Skills

Scientific problem solving

Microsoft Office

Analytical software

English language

Education

PharmD or PhD with 3+ years in clinical research

MS with 6+ years relevant experience

BS or RN with 8+ years relevant experience

Job description

Syneos Health is seeking a Principal Research Scientist ONC - Clinical Development Scientist for sponsor-dedicated or remote US work. The role focuses on coordinating the development and validation of bioanalytical methods within client timelines, partnering across study design and regulatory submission teams.

Responsibilities include protocol development, CRF/Data Plan contributions, and support for regulatory submissions, with emphasis on GCP compliance and scientific problem solving.