Clinical Scientist

• Monitor, review, and summarize safety and efficacy data in 1 or more ongoing studies on a regular basis
• Work in close collaboration with the clinical team to ensure translation of the clinical protocol (and amendments) into operational deliverables, including but not limited to performing ongoing review and analysis of clinical study data and preparing/reviewing study plans (i.e., Medical Monitoring, Medical Data Review, Safety Management, CRF Completion Guidelines, etc.)
• Respond to study questions from sites and/or vendors, with study medical monitor or Clinical Development supervision where needed
• Perform literature search and critically review and summarize the relevant scientific, drug development, and medical literature to support new clinical trial design as well as the development of clinical and/or regulatory documents
• Support preparation of scientific material
• Contribute to the development of SOPs and associated guidelines and templates
• Participate in cross-functional team meetings with members from clinical operations, safety, regulatory, biostatistics and data management

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more. [“Human”]