Director, Data Management

Role: Provide strategic and operational leadership for Clinical Data Management (CDM) activities supporting biopharma clinical development programs. Responsibilities: oversee all CDM deliverables for internal studies, manage CRO vendors, ensure compliance with GCP, ICH, 21 CFR Part 11, develop data management strategies, oversee database design, validation, and maintenance, ensure inspection readiness, maintain data standards and documentation, collaborate closely with Biostatistics and Programming, monitor departmental metrics, lead initiatives on process improvements, and manage staff development and cross-functional governance. Requirements: Bachelor's in Life Sciences or related field; minimum 10 years in clinical data management within pharma/biotech, with at least 3 years in leadership roles; experience managing global trials and cross-functional teams; advanced knowledge of GCP/ICH standards and 21 CFR Part 11; proven leadership, organizational, and interpersonal skills. Preferred: CCDM experience. High-Value: leadership in clinical data management for biopharma, supporting diverse clinical trials, regulatory compliance, GxP, and cross-functional collaborations. Work setup: hybrid environment based in Waltham, MA, with at least 60% onsite presence and some remote work; travel not specified but implied for vendor oversight and cross-site coordination.