Associate Director, Clinical Data Management
About the role
Life at BMS At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ The Associate Director, Clinical Data Management, will play a crucial role in our data management efforts, ensuring the accuracy, consistency, and integrity of clinical data. This position involves leading and overseeing all aspects of data management, from planning and coordination to execution and quality control. The successful candidate will be responsible for managing relationships with external partners and collaborating across cross-functional teams to ensure data deliverables and expectations are met.
Responsibilities
- Provide data management leadership, insight, and support to all internal and external projects and clinical trials. May simultaneously function as lead Clinical Data Manager for multiple clinical trials.
- Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
- Manage and provide oversight of data management personnel and activities of CROs and vendors.
- Ensure CRO adherence to project timelines, from study startup to study closeout, while maintaining high quality and integrity of deliverables.
- Engage in cross-functional meetings, providing updates on project status, issues, and milestones.
- Review data using listings and visualization tools for performance and quality reporting, conducting reviews within studies and across multiple studies for trend analysis.
- Lead interactions with third-party vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study-specific data.
- Proficient in clinical systems, including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed.
- Contribute to SOP development and updates to meet regulatory compliance and operational needs.
- 10% of travel required.
Requirements
- Bachelor’s degree
- Minimum of 6 years of data management experience in pharmaceutical/biotech/CRO industry
- Extensive hands-on experience in all aspects of data management.
Qualifications
- Bachelor’s degree in Life Science, mathematics, or health-related fields
- Experience in the Oncology therapeutic area
Skills
- Proven ability to manage CRO relationships and oversee data management deliverables.
- Strong knowledge and experience of EDC systems (Medidata RAVE or Veeva).
- 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.
- Applies AI to improve team