Lead Clinical Data ManagerKatalyst HealthCares & Life Sciences • Durham, NC
Lead Clinical Data Manager
Katalyst HealthCares & Life Sciences • Durham, NC
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
Responsibilities:
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.
- Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
- A minimum of + 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 (, 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 (, ePRO, wearables, AI/ML applications)
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Lead Clinical Data Manager • Durham, NC
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