Senior Manager, Clinical Data Management

Role: Associate Director, Clinical Data Programmer at Amylyx, providing technical leadership and hands-on support in clinical data management for early- to late-phase trials. Responsibilities: oversee data management activities, develop project timelines, ensure quality of study-specific documentation (eCRFs, data management plans), manage CRO/vendor deliverables, perform testing of eCRFs, and support audit readiness. Collaborate with internal teams (Biometrics, Clinical Operations, Regulatory) and external vendors, monitor vendor performance, and escalate issues as needed. Requirements: Bachelor’s in Life Science or related field; at least 6 years of clinical data management experience, including CRO/vendor management; strong knowledge of FDA, ICH/GCP, CDISC standards, and GxP regulations. Preferred: experience in Phase III trials, supporting audits/regulatory inspections, proficiency with Medidata Rave EDC, and CDC certification. High-Value: clinical stage, focus on innovative therapeutics for high unmet needs (PBH, Wolfram syndrome, ALS), global/cross-cultural work environment. Work setup: remote within the US with regular travel to Cambridge, MA; travel expected several times a year.