Director of Clinical Data Management

Role Summary

Director of Clinical Data Management leads end-to-end CDM activities on assigned studies and programs, oversees 3rd party data sources, and serves as SME for Data Management within the Biometrics group. Collaborates with cross-functional teams within Clinical Development and larger Data Science functions. Responsible for CDM study activities, document reviews, CRO oversight, timelines, and project risk management across multiple projects in a fast-paced environment. This is a hybrid, office-based role in Salt Lake City, UT or New York City, NY requiring in-office presence at least 50% of the time.

Responsibilities

• Provide strategic and hands-on leadership for end-to-end Clinical Data Management across outsourced studies, with expertise in EDC build, external data acquisition, reconciliation, standards implementation, and database lock activities.
• Lead 3‚Äì4+ outsourced programs simultaneously with full oversight of vendor performance, data quality, deliverables, timelines, and operational risks.
• Represent CDM in study meetings and governance forums, ensuring proactive issue resolution, transparent communication, and alignment of data-related expectations.
• Oversee EDC design, configuration, testing, and integration of systems such as IRT, ePRO/eCOA, imaging, wearables, and other external data sources, providing technical direction to vendors.
• Develop Vendor Oversight Plans and ensure continuous monitoring of data quality, compliance, KPIs, and audit readiness.
• Serve as the technical SME for CDM systems, data standards, data flow architecture, SDTM alignment, and operational processes.
• Lead the development and standardization of CRFs, Data Review Plans, edit checks, and cross-functional data workflows to ensure consistency and high-quality data capture.
• Oversee the creation and review of CDMPs, CCGs, edit check specifications, data transfer and reconciliation plans, DVPs, and database lock documentation.
• Ensure vendor data collection and external data approaches align with Recursion standards and SDTM/ADaM requirements to support downstream analysis and regulatory submissions.
• Drive strategic initiatives to modernize CDM operations, enhance scalability, strengthen data pipeline efficiency, and improve inspection readiness.
• Guide submission-related CDM activities, ensuring data traceability, integrity, and regulatory compliance.
• Manage Data Management budgets, analyze cost trends, support forecasting, and contribute to vendor negotiation strategies.
• Thrive in a fast-paced, evolving environment where priorities and protocols shift rapidly, maintaining flexibility, resilience, and a solution-oriented mindset.
• Collaborate with cross-functional partners including Biostatistics, Statistical Programming, Medical Monitoring, Clinical Sciences, Regulatory, QA, and Clinical Operations to ensure aligned data strategy and seamless study execution.
• Support the development and continuous improvement of CDM SOPs, Work Instructions, and standard templates to ensure operational consistency and quality.
• Ensure compliance with GCP, regulatory requirements, and CDM best practices.

Qualifications

• Bachelor‚Äôs degree in science, math or computer science
• 14+ years‚Äô experience in the biopharmaceutical industry. Experience, technical proficiency and People management skills will determine the level.
• Experience managing external data and 3rd party vendors is a must.
• Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
• Excellent written and verbal communication skills and ability to work collaboratively as a part of a team.

Education

• Bachelor‚Äôs degree in science, math or computer science