Send Specialist II

Role: Send Specialist II responsible for preparing and submitting final SEND datasets for nonclinical studies. Objectives include ensuring compliance with current regulations, generating accurate SEND datasets, and supporting process improvements. Responsibilities: create SEND datasets using electronic systems, review and QC data against study reports and protocols, develop nSDRG and Define files, collaborate with third-party vendors, participate in industry training, and assist in training new staff. Engage with Study Directors, Principal Investigators, and cross-functional teams to meet milestones. Qualifications: B.S. degree or 2-5 years industry experience; strong attention to detail; knowledge of CDISC, SENDIG, FDA GLPs, and nonclinical study design; familiarity with statistical tools like SAS or Prism preferred. High-Value: expertise in nonclinical data management, SEND implementation, regulatory compliance, and QC review within the context of preclinical studies. Work setup: primarily office-based with potential for hybrid arrangements; physical activity includes computer work and light lifting; may require PPE and biological safety precautions.