Senior Associate, Clinical Data Standards Management (CDSM)

Role: Senior Associate, Clinical Data Standards Management, supporting global clinical data standards development, implementation, and maintenance within biopharma, specifically for cancer immunotherapies. Responsibilities: collaborate cross-functionally with Data Management, Clinical Programming, Biostatistics, and Clinical Operations to develop and maintain standards (CDISC, CDASH, SDTM), support global library releases, assist in study-level standards application, and ensure regulatory compliance. Involved in process improvements, standards governance, and quality assurance during EDC setup across studies. Qualifications: Doctorate with Clinical Data Standards or EDC programming experience; or Master’s with 3+ years; or Bachelor’s with 5+ years relevant experience. Preferred skills include working knowledge of CDISC standards, Medidata Rave EDC modules, clinical data management processes, and GxP regulations. High-Value specifics: focus on clinical data standards in oncology, with involvement in global library development, GCP/ICH compliance, and regulatory standards (FDA, EMA). Collaboration with standards governance committees and study teams is key. Work setup details are not specified, but the role involves cross-functional, technical, and potentially global interactions.