Senior Manager, Clinical Data Management

About the role

As a Senior Manager, Clinical Data Management at RayzeBio, you will play a crucial role in our data management efforts, ensuring the accuracy, consistency, and integrity of clinical data. This position provides oversight of data management activities, from planning and coordination to execution and quality control.

Responsibilities

• May simultaneously function as lead Clinical Data Manger for multiple clinical trials.
• Covers day-to-day data management study tasks, including reviewing data management documents to ensure a consistent approach.
• Reviews project timelines and metrics to ensure databases are delivered on schedule.
• Ensures the data collected meets the requirements of the study objective and company quality standards.
• Engages in cross-functional meetings, providing updates on project status, issues, and milestones.
• Provides oversight of data management personnel and activities of CROs and vendors.
• Leads interactions with third-party vendors (e.g., laboratories) on collection, transmittal, and transfer of study-specific data.
• Reviews data using listings and visualization tools to support performance and quality reporting; conducts study-level reviews to identify trends.

Requirements

Experience with clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed.

Qualifications

• Bachelor’s degree in Life Science, mathematics, or health-related fields preferred.
• Minimum of 4 years data management experience in pharmaceutical/biotech/CRO industry; extensive hands-on experience in all aspects of data management.
• Experience with clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools.
• Experience in the Oncology therapeutic area is preferred.
• Proven ability to manage CRO relationships and oversee data management deliverables.
• Strong knowledge and experience of EDC systems (Veeva preferred).
• Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations.
• Excellent verbal and written communication skills.
• Strong analytical and problem-solving abilities.