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Lead Clinical Data Manager

Katalyst Healthcares & Life Sciences | Durham, North Carolina, United States | Posted May 10, 2026

Position Overview

Responsibilities:

  • Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards.

  • Provide strategic oversight and direction to CRO clinical data management teams for assigned studies.

  • Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements.

  • Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality.

  • Conduct thorough reviews of clinical data, identifying trends, inconsistencies, and potential issues that may impact data quality or study outcomes.

  • Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignmen...

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