Director, Clinical Data Management

Role: The Director of Clinical Data Management provides strategic leadership and operational oversight of data management in clinical trials, ensuring data quality, integrity, and regulatory compliance. Responsibilities include developing and implementing data management strategies, managing CROs and vendors, designing data collection tools (e.g., eCRFs), overseeing database cleaning, data reconciliation, and supporting regulatory submissions and audits. The role involves cross-functional collaboration with Clinical Operations, Biostatistics, and other teams, as well as mentoring staff and managing external partnerships. Qualifications: Bachelor's degree in science or healthcare with at least 10 years of experience in clinical data management within biopharma, CRO, or regulatory settings. Strong leadership background in managing data management teams and vendors, with expertise in Medidata RAVE, relational databases, data standards (CDISC, GxP, 21 CFR Part 11), and regulatory guidelines (FDA, ICH). Technical skills include proficiency in data visualization tools, SQL, SAS, and database programming. Preferred: extensive experience with Medidata RAVE, CDISC standards, and knowledge of global regulatory requirements. The position requires approximately 25% travel, based in Warren, NJ, with a hybrid work model.