Sr Clin Data Mgmt Assoc

Role: Senior Data Management Associate supporting Kite's oncology clinical development programs, primarily overseeing data management activities from study start-up to close-out. Responsibilities include collaborating with Biostatistics, Programming, Clinical Operations, and external vendors to ensure high-quality, timely data collection, cleaning, and reporting; designing eCRFs; reviewing protocols; managing data transfer processes; and maintaining compliance with regulatory standards. The role involves handling complex studies, leading data management efforts independently, and ensuring data integrity throughout all phases.

Qualifications: High School diploma with 9+ years, BS/BA with 5+ years, MS/MA with 3+ years, or PhD with 2+ years in Data Management or related life sciences field. Proficiency in electronic data capture systems (e.g., Medidata Rave), strong communication skills, and experience managing clinical trial data are required.

Preferred: Oncology or hematological cancer experience, knowledge of lab data, familiarity with FDA/EMA/ICH regulations, and industry-standard vocabularies like MedDRA.

High-Value Details: Focus on clinical data management within cancer immunotherapy, including cell therapy data, with potential involvement in regulatory submissions. The role reports to the Senior Manager, Clinical Data Management, and may involve cross-functional interactions across Clinical, Biostatistics, and Regulatory teams. Located in Santa Monica, CA, with a flexible work environment.