Associate Director, Clinical Data Management

Role: Associate Director, Clinical Data Management, leading data management activities for Summit’s oncology clinical trials across various phases, including late-phase and global studies. Core responsibilities include designing eCRFs, overseeing database development, validation, and data review, managing CROs/vendors, and ensuring data quality, integrity, and regulatory compliance. The role involves cross-functional collaboration with Clinical Operations, Biostatistics, Regulatory, and IT teams, and supporting clinical trial audits. Requirements: Bachelor's in Life Sciences, Computer Science, or related field; 10+ years in Clinical Data Management within biotech/pharma, with oncology experience preferred. Expertise in EDC systems, coding standards (MedDRA, WHODRUG), and FDA/ICH regulations is essential. Leadership experience managing CDM teams and CRO oversight is required. HighValue: oncology (preferably in late-phase trials), global/regional studies, GCP, ICH, FDA compliance, CRO/vendor oversight, and experience with regulatory audits. WorkSetup: not specified; likely hybrid or onsite considering seniority and scope.