Lead Clinical Data Manager job at cGxPServe. Boulder, CO. 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).