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Senior Director, Clinical Data Management

Bristol-Myers Squibb

RemoteRemote - United StatesStaffH-1B sponsor company
Sign in to applyVerified 1d ago
Location
Remote - United States
Work model
Remote
Level
Staff
H-1B history
57 approvals (FY2023)
Posted
1d ago

Skills

GCP

About this role

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 Senior Director, Head of Data Management, will lead data management activities for clinical development. This role is critical in establishing and managing data management strategy, ensuring high-quality database build, data integrity, and inspection readiness to support pivotal studies and regulatory submissions. The Senior Director will provide leadership across studies and programs, collaborating cross-functionally to ensure aligned data strategies, while driving efficiencies through process standardization, SOP development, vendor oversight, and implementation of automation and advanced technologies.

Job Responsibilities

Lead and oversee data management activities across the clinical portfolio, ensuring high-quality, timely, and compliant data deliverables for all studies Provide strategic leadership for data management in support of NDA submissions, including database lock, submission readiness, and regulatory inspection preparedness Build, lead, and develop the data management team, including hiring, performance management, and capability development Serve as the primary interface with external partners to ensure alignment on data standards, processes and resource planning Oversee vendor strategy and performance across all studies, including selection, budget management, timeline oversight, and quality assurance Drive standardization of data management processes and lead development and implementation of SOPs to support scalable and inspection-ready operations Establish and maintain efficient database build, data cleaning, and data review processes across studies, ensuring consistency and quality Lead database strategy, including build, validation, and lock processes across studies, ensuring timely and high-quality delivery Partner cross-functionally with Clinical Operations, Clinical Development, Biostatistics, and Safety to ensure alignment on study execution and data quality Skills and Knowledge: 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.

Basic Requirements

Bachelor’s or Master’s degree in Life Sciences, Computer Science, Mathematics, Health Sciences, or a related field required. Minimum of 12 years data management experience in pharmaceutical/biotech/CRO industry. Demonstrated experience in team leadership and management. Ability to guide, mentor, and develop team members. In-depth experience in the Oncology therapeutic area is required. Proven ability to manage CRO relationships and oversee data