Clinical Scientist, Early Clinical Development

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Position Summary 

• Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct. 

• May lead or support trial level activities for one or more trials with the necessary supervision. 

Duties/Responsibilities  

• 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.  

• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.   

• Conduct literature review.  

• Develop site and CRA training materials and present these at SIVs and Investigator meetings.   

• Review clinical narratives.   

• Collaborate cross-functionally to monitor clinical data for specific trends.   

• Contribute to the development of 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.   

• Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)  

• Submit clinical documents to TMF. 

Reporting Relationship 

Director, Clinical Science Early Clinical Development (HOCT) 

Qualifications 

Specific Knowledge, Skills, Abilities: 

• Basic planning/project management skills (develop short range plans that are realistic and effective).   

• Basic knowledge of disease area, compound, current clinical landscape.   

• Detail-oriented with commitment to quality  

• Intermediate critical thinking and problem-solving skills.   

• Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism). 

• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report gener