Lead Clinical Data Manager Job at cGxPServe, Irvine, CA

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  • cGxPServe
  • Irvine, CA

Job Description

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 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.

Requirements:

  • Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
  • A minimum of 7+ years of clinical data management experience in the biotechnology or pharmaceutical industry.
  • Experience managing oncology clinical trials data, including a deep understanding of oncology-specific data requirements and challenges.
  • Expert-level proficiency with Medidata Rave EDC, including system configuration, form design, and edit check programming.
  • Strong knowledge of clinical research processes, FDA & ICH guidelines, GCP, GCDMP, and CDISC standards.
  • Demonstrated experience in CRO and vendor oversight.
  • Excellent project management skills with the ability to manage multiple studies simultaneously.
  • Strong analytical and problem-solving skills with meticulous attention to detail.
  • Outstanding communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders.
  • Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g., SAS, R) is a plus.
  • CCDM (Certified Clinical Data Manager) certification.
  • Experience with risk-based monitoring in oncology studies.
  • Knowledge of emerging technologies in clinical data collection and management (e.g., ePRO, wearables, AI/ML applications).

Job Tags

Work at office,

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