Senior Director, Clinical Systems and Compliance

Role: Senior Director of Clinical Development Operations, leading strategy, oversight, and compliance of clinical systems and documentation processes to support global clinical trials. Responsibilities include partnering with IT on system evaluation, implementation, and optimization; managing quality, compliance, and inspection readiness activities; providing strategic oversight of Trial Master File (TMF), and supervising the Clinical Documentation Group. Qualifications: Bachelor's in a scientific or healthcare discipline; 13+ years in clinical development, operations, or quality, with experience supporting systems like EDC, IRT, and eTMF; prior leadership preferred. HighValue: extensive GxP, GCP, ICH, FDA regulation knowledge; experience with clinical trial systems, audits, CAPA, and inspection readiness; cross-functional collaboration across clinical ops, IT, and quality; supporting global clinical trials. WorkSetup: not specified.