Director of Clinical Data Management

Role Summary

Your work will change lives. Including your own.

Responsibilities

• Provide strategic and hands-on leadership for end-to-end Clinical Data Management across outsourced studies, requiring extensive technical expertise in EDC build, external data acquisition, reconciliation, standards implementation, and database lock activities.
• Lead 3–4+ 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 effectively 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

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

Education

• Bachelor’s degree in science, math or computer science

Skills

• End-to-end Clinical Data Management
• EDC systems design, configuration, and validation
• External data acquisition and data integration
• SDTM/ADaM standards
• CRF development, Data Review Plans, and edit checks
• Vendor oversight and management of CROs
• Regulatory compliance and GCP
• Cross-functional collaboration (Biostatistics, Programming, Medical Monitoring, Regulatory, QA, Clinical Operations)