Lead Data Manager

Role: Lead Data Manager overseeing all data management activities for clinical studies in a biopharma setting focused on MASH therapeutics, including Rezdiffra (resmetirom). Responsibilities: manage end-to-end data activities from study start-up to database lock, develop Data Management Plans, lead EDC system setup and testing, coordinate data review and cleaning, monitor study progress, and ensure compliance with GCP, ICH, and regulatory standards. Serve as primary contact for CROs and external vendors, contribute to process improvements, and mentor junior staff. Qualifications: Bachelor's degree in Life Sciences, Computer Science, or related field; 5–7 years of clinical data management experience, with proficiency in EDC systems like Medidata Rave, Oracle InForm, or Veeva CDMS. Strong understanding of CDASH, SDTM standards, and regulatory guidelines, with vendor management skills. Preferred: experience leading data management for Phase II or III global trials, familiarity with adaptive trial designs, and management of data across multiple external vendors. High-Value Specifics: focus on metabolic disorders, biologics or small molecules, active Phase 3 outcomes trial for MASH cirrhosis, and a collaborative cross-functional environment. Work setup: not explicitly stated but involves external collaborations and vendor oversight.