Clinical Scientist

Clinical Scientist, Early Development Research

The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.

Responsibilities include:

• Design and execution of assigned clinical trial activities
• Collaboration with clinical team members to execute trial conduct activities
• Leading or supporting trial level activities with necessary supervision
• Collaborating and liaising with external partners
• Seeking out and enacting best practices with instruction
• Providing regular and timely updates to manager/management
• Collaborating cross-functionally to develop protocol and ICF documents/amendments
• Conducting literature reviews
• Developing site and CRA training materials
• Reviewing clinical narratives
• Monitoring clinical data for specific trends
• Contributing to the development of Data Review Plan in collaboration with Data Management
• Ensuring CRF design supports data collection in alignment with the protocol
• Authoring/reviewing clinical contributions to clinical study reports and clinical portions of regulatory documents
• Submitting clinical documents to TMF

Preferred qualifications:

Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred). Expectation of 2+ years of experience in clinical science, clinical research, or equivalent. Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations. Intermediate medical writing skills and medical terminology. Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees. Basic planning/project management skills. Basic knowledge of disease area, compound, current clinical landscape. Detail-oriented with commitment to quality. Intermediate critical thinking and problem-solving skills. Adaptable/flexible. Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools.

Domestic and international travel may be required (approximately 10-20%)