Associate Director, Clinical Data Management

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio 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 Rayze Bio:

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.

• 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.
• Travel is required, approximately 10%.

• Bachelor's degree in Life Science, mathematics, or health-related fields preferred.
• Minimum of 6 years data management experience in pharmaceutical/biotech/CRO industry; extensive hands-on experience in all aspects of data management.
• 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 (Medidata RAVE 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.

• While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision.

• The noise level in the work environment is usually moderate.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation varies by location. Example ranges listed below.

• Princeton, NJ, US: $173,217 - $209,899
• San Diego, CA: $190,539 - $230,888

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the…