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Senior Manager, Global Clinical Scientist (Cell Therapy)

Scorpion Therapeutics

Position Summary / Objective Responsible for design and execution of assigned clinical trial activities and work closely with clinical team members to execute activities associated with trial 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 necessary supervision. May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members. Position Responsibilities Collaborate and liaise with external partners (e.g., KOLs). Seek out and enact best practices. Provide regular and timely updates to manager/management as requested. Develop Protocol and ICF documents/amendments and present to governance committee and development team meetings. Conduct literature review. Submit clinical documents to TMF. Develop site and CRA training materials and present at SIVs and Investigator meetings. Review clinical narratives. Monitor clinical data for specific trends. Develop Data Review Plan with Data Management. Ensure CRF design supports data collection aligned with protocol (with Data Management/Programming). Submit clinical contributions to CSRs and clinical portions of regulatory documents and contribute to regulatory submissions. Degree Requirements Degree in Life Sciences (MD, PhD, PharmD, MS, RN or other scientific field preferred). Experience Requirements Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations. Ability to understand assigned protocol requirements. Basic skills for program-specific data review and trend identification. Intermediate medical writing skills and medical terminology. Basic planning/project management skills. Key Competencies Detail-oriented; commitment to quality. Basic knowledge of disease area/compound/clinical landscape. Basic knowledge of data monitoring/dose review/independent response adjudication committees. Intermediate critical thinking/problem-solving. Adaptable/flexible. Intermediate MS Word/Excel/PowerPoint and data review tools. Travel Required Domestic and international travel may be required. #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 2 days ago
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