Director, Clinical Data Management

Key Accountabilities / Core Job Responsibilities

• Provide leadership and oversight for the execution of clinical data management (CDM) activities across multiple therapeutic areas and molecules. Lead CDM activities at the project or study level, as needed.
• Manage a team of Managers and Clinical Data Associates, ensuring effective support for complex data management needs and fostering a productive, skilled workforce. Direct and guide team through DM lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials.
• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
• Drive CDM organizational strategy and lead the implementation of change initiatives, focusing on enhancing processes, systems, and productivity including implementation and maintenance of data standards.
• Collaborate with Clinical Programming, Data Science, Clinical Operations, Biostatistics, and other departments to meet project deliverables, ensuring alignment and timely data acquisition.
• Lead initiatives to improve data management processes, including recommending new operating procedures and implementing advanced tools to increase efficiency and reduce errors.
• Ensure compliance with FDA, EMA, and other global regulatory standards, and lead the preparation of responses to regulatory audits and quality assurance findings.
• Anticipate internal resource needs, manage external costs, and work with senior management to ensure long-term resource allocation for data management functions.
• Oversee vendor performance and manage the implementation of new systems and tools, including Electronic Data Capture (EDC) systems, to enhance productivity. Ensure the processes, procedures, data deliveries, timelines and study documentation created are of high quality, compliant with study requirements, SOPs, and GCPs.
• Lead efforts to address complex issues such as system downtime and vendor performance, ensuring minimal disruption to clinical trial data processes.
• Ensure effective communication of functional issues across teams and stakeholders, and lead efforts to communicate changes in priorities or plans clearly and promptly.

Qualifications/Skills

• BA/BS or higher in math, science, or health-related field; typically requires 10+ years of CDM experience in biotech, pharmaceutical, or health-related industry, including 5+ years of people-management experience.
• Strong experience with data standards, EDC systems, and managing vendors/CROs
• Thorough knowledge of FDA regulations, ICH-GCP, SDTM, CDISC, database development, UAT, medical coding, and the drug development process
• Prior experience supporting regulatory submissions, (NDAs, sNDAs, BLAs,) as well as preparing for and supporting regulatory inspections and audits, is strongly preferred.
• Knowledge of non-CRF data flow/transfer/integration and the DM lifecycle for non-interventional, exploratory, and Phase 1–3 studies (pivotal, blinded, randomized)
• Excellent supervisory, problem-solving, negotiation, and organizational skills
• Strong team-building and resource-allocation experience