Clinical Scientist

CLINICAL SCIENTIST SUMMIT, NJ Position may start remote then move to a hybrid schedule once restrictions are lifted . Project Description:

• The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
• Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct .
• May serve as Clinical Trial Lead for one or more trials .
• May lead or support trial level activities for one or more trials with the necessary supervision .
• May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members .
• Collaborate and liaise with external partners (e.g., KOLs) .
• Seek out and enact best practices with instruction .
• Provide regular and timely updates to manager/management as requested .
• Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required .
• Conduct literature review .
• Submit clinical documents to TMF .
• Develop site and CRA training materials and present these at SIVs and Investigator meetings .
• Review clinical narratives .
• Monitor clinical data for specific trends .
• Develop Data Review Plan in collaboration with Data Management .
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming .
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission) .

• 2+ years of experience working on clinical trials .
• Previous role as a Clinical Scientist, or Clinical Manager/Study Lead .
• Experience with writing study protocols .
• Experience with clinical trial data review and cleaning .
• Advanced Science degree (or additional years of experience if no advanced Science degree) .