Lead Clinical Data Manager

Lead Clinical Data Manager Katalyst Healthcares & Life Sciences - 4.0 Cambridge, MA Job Details Contract 6 hours ago Qualifications Research project management Database systems development Clinical trial risk management Configuration management ICH guidelines Vendor performance evaluation Bachelor's degree CDISC standards Risk management Vendor performance improvement Vendor relationship management Vendor communication System development Managing projects Clinical quality assurance standards Cross-functional collaboration Cross-functional communication

Full 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).