Associate Director, Data Management

Role: Associate Director, Data Management overseeing clinical trial data quality and integrity within biopharma development, primarily in rare disease programs, with a focus on regulatory compliance and process improvements. Responsibilities: lead start-up and execution of trials in collaboration with CROs and internal teams, develop and manage data management timelines, perform data review and discrepancy resolution, lead audits and inspections, and guide cross-functional teams in data-related activities. Qualifications: Bachelor's in life sciences or related field; 8+ years of data management experience, including vendor management and EDC systems proficiency (preferably Medidata RAVE). HighValue: extensive experience with clinical data standards (CDASH, SDTM), managing outsourced studies, GxP, ICH/GCP guidelines, and knowledge of coding dictionaries (MedDRA, WHODrug). Collaboration: work closely with clinical trial teams, vendors, and internal departments; reports to senior leadership. Work setup: Remote in San Diego with approximately 10% travel.