Director, Clinical Data Management

Job Description Summary

The Director, Clinical Data Management provides strategic and operational leadership and oversight of data management activities to ensure the quality, integrity, consistency, and inspection readiness of clinical databases for subsequent analysis, reporting, and regulatory submissions. This position proactively develops plans for utilizing EDC system processes and other clinical data applications, leads and contributes in defining sponsor processes and procedures for maintaining clinical data, and oversees QA/QC documentation.

She/He may have supervisory responsibilities for internal staff and external consultants and may manage direct reports. The incumbent works cross‑functionally with various internal departments and external resources on data‑management issues and ensures adherence to regulatory requirements and the company SOPs.

• Ensure the data collected meets the requirements of the study objective and company quality standards.
• Drive the development and implementation of strategic vision for the DM group.
• Provide functional oversight of CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
• Partner with Clinical Operations, biostatisticians, SAS programmers and other staff as appropriate to design and develop data collection instruments (e.g., eCRF) to ensure the required information is captured for statistical analysis.
• Oversee and, as needed, directly support coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding.
• Lead data management activities, clinical database cleaning in EDC, data reconciliation with external vendor data, SAE reconciliation and lock activities.
• Lead development of data management plans, data review plans, supervise database development, and review and process clinical trial data to ensure completeness, accuracy, and consistency.
• Prepare and distribute or facilitate distribution of periodic reports of study status including CRF completion status, missing pages, query aging, clean patient tracker, etc.
• Participate in cross‑functional team meetings, communicate with all departments regarding project status/issues, and provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.
• Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study‑specific data.
• Develop and update SOPs and other documents associated with data collection, handling, and review processes, e.g., Working Instructions, Best Practices Documents to meet regulatory compliance and operational needs.
• Facilitate and contribute to regulatory submissions and audit/inspection activities.
• Gather requirements related to existing clinical systems to identify opportunities to enhance, improve and streamline processes and systems use.
• Lead the assessment and selection of Data Management vendors and systems for clinical data collection and analysis.
• Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
• Mentor clinical team members by resolving problems and providing DM guidance.
• Manage multiple and varied tasks, prioritize workload with attention to detail.
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team.
• Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on patients and customers as top priorities.
• Lead the completion of data management activities to meet project timelines and communicate status to respective team members.
• Contribute to the development of outsourcing strategies and relationships with outsourcing partners and may play a role in identifying quality DM partners including coordinating the review and approval of the Master Services Agreement.
• May manage, coach, and mentor direct reports.
• Perform other tasks and assignments as needed and specified by management.

• Minimum level of education and years of relevant work…