Job Description:
We are seeking an experienced Clinical Data Manager. The successful candidate will ensure that CDM deliverables are completed on time, within budget, and in accordance with quality standards and study requirements.
Key Responsibilities:
- Leadership & Oversight: Provide leadership for the CDM function, overseeing multiple trials and ensuring adherence to project goals, scope of work, and service agreements.
- Vendor Management: Oversee CRO and CDM vendors to ensure successful project execution.
- Collaboration: Establish and maintain strong relationships with internal cross-functional teams, vendors, and clinical research site personnel.
- EDC Management: Lead and oversee Electronic Data Capture (EDC) build, migration, and deployment, including user acceptance testing and data integrations with external vendor data sources (e.g., IRT, laboratory, imaging).
- System Set-Up: Oversee the set-up of other clinical management systems (e.g., IxRS) and data transfer agreements with external vendors.
- Documentation: Write or contribute to the preparation of CDM documents.
- Report Development: Lead the development of EDC custom and Business Objective reports, SAS clinical programming report specifications, and data visualization outputs.
- Clinical Document Review: Collaborate with the Study Execution Team (SET) to review clinical documents such as protocols, statistical analysis plans, and mock tables.
- Metrics & Trends: Report DM metrics and trends, identify barriers to trial execution, and propose solutions.
- Data Review: Lead clinical data review of data listings and summary tables with the SET.
- Data Strategy: Implement data review strategies using data integration or visualization platforms.
- Expertise: Serve as a subject matter expert on CDM systems and processes.
- Standardization: Lead CDM standardization and develop Standard Operating Procedures, work instructions, and other infrastructure as needed, including standard CDASH case report form libraries and associated edit checks.
Qualifications:
- Proven experience in end-to-end clinical data management.
- Experience working in early phase oncology trail management experience preferred
- Strong leadership and project management skills.
- Excellent communication and collaboration abilities.
- Expertise in Veeva Vault EDC systems and other clinical management systems.
- Familiarity with SAS clinical programming and data visualization tools.
