Director, Standards & Database Design (Clinical Data Management)

Role: The Director, Standards and Database Design Lead, is a senior management position responsible for establishing and governing Tyra's clinical data standards and overseeing the design, build, and validation of clinical data management systems. Main objectives include ensuring data standards compliance, inspection readiness, and system quality across all trials. Responsibilities encompass managing CDISC standards (CDASH, SDTM, ADaM), study database design, CRF/eCRF development, vendor oversight, and system validation in accordance with GxP and regulatory requirements. The role also involves strategic planning for transitioning studies in-house, vendor and platform governance, and potentially building and leading an in-house study build team as the organization evolves. Qualifications include a bachelor’s degree in Life Sciences, Computer Science, or related field, with 12+ years of clinical data management experience—preferably in biotech or pharma—focusing on data standards and database design, and 3+ years of leadership experience. Proficiency with commercial EDC platforms (Medidata Rave, Veeva Vault) and experience maintaining validated systems per 21 CFR Part 11 are required. Experience supporting oncology or pediatric studies across Phases I-III is preferred. Collaboration involves Data Management leadership, vendors, and cross-functional teams. The position is remote with no specified travel.