Senior Manager, Clinical Data Management

Role: Associate Director, Clinical Data Programming at Amylyx, providing technical leadership and hands-on programming support for clinical data management in late-stage trials. Responsibilities: oversee development, validation, and maintenance of clinical databases; lead programming of data access, visualization, and reporting; manage cross-functional collaborations with Biometrics, Clinical Operations, vendors, and regulators; ensure adherence to ICH, FDA, and GCP standards; perform risk mitigation and support audit readiness. Requirements: Bachelor's in Life Sciences or related; 6+ years in clinical data management, experience with CRO/vendor oversight, strong knowledge of FDA/ICH/GCP regulations, CDISC standards, and eTMF documentation; excellent communication and organizational skills. Preferred: experience in Phase III trials, supporting audits, expertise with Medidata Rave EDC, and certification as Clinical Data Manager. High-Value: clinical stage biotech focus on rare and severe diseases (PBH, Wolfram syndrome, ALS), remote work within the U.S., with periodic travel to Cambridge, MA. Compensation: $156,000—$175,000 USD.