Lead Clinical Data Manager

Clinical Data Management Lead

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 alignment of data management strategies with overall clinical development goals.

Provide oversight, and performance management of external data management vendors.

Maintain SOPs, guidelines, and best practices for clinical data management processes.

Represent the Clinical Data Management function in internal and external meetings, providing expert guidance on data-related matters.

Stay current with industry trends, regulatory requirements, and technological advancements in clinical data management, particularly in the oncology field.