Associate Director, Clinical Data Management

The Associate Director, Clinical Data Management will serve as a senior Data Management Lead and strategic data management leader across assigned clinical studies. This role will provide end-to-end leadership from protocol review and study start-up through database lock, regulatory submission support, long-term follow-up, and archival, while ensuring high-quality, analysis-ready clinical data. Responsibilities: Serve as senior Data Management Lead for assigned clinical studies across multiple phases, providing end-to-end leadership from protocol review through database lock, long-term follow-up, and archival. Review protocols and study strategies to ensure feasible, compliant, and effective data collection. Lead EDC, CRF, edit check, query logic, user requirements, and CRF completion guideline development. Oversee external data integrations, transfers, reconciliation, medical coding, and validation. Develop and maintain data management plans, database specifications, validation records, UAT documentation, and data review plans. Lead cross-functional data review and align stakeholders on quality, timelines, and risk mitigation. Oversee CROs and vendors, including selection, performance, quality, timelines, budgets, and change orders. Drive study and program milestones, proactively identifying risks and implementing solutions. Lead database testing, UAT, data cleaning, coding, reconciliation, database lock, and archival. Review data listings and support analyses, safety monitoring committees, endpoint adjudication, and submissions. Support regulatory submissions, health authority responses, inspection readiness, and audits. Ensure compliance with GCP, applicable FDA and ICH requirements, company procedures, industry standards, and applicable CDISC standards. Contribute to data standards, SOPs, technology assessments, and continuous process improvement. Provide leadership, mentoring, and technical guidance to data management staff. Represent Clinical Data Management on cross-functional teams and communicate status, risks, and resource needs. Qualifications: