Manager, Clinical Data Management

Ultragenyx

full-time

Posted on: 9/22/2025

Origin: • 🇺🇸 United States

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💰 $141,500 - $174,800 per year

Mid-LevelSenior

GoGoogle Cloud PlatformOracle

About the role

Accountable for the overall success of Data Management for their program(s).
Operational leadership and support of data management activities for one or more programs.
Represent data management on cross-functional team providing accurate study status updates and proactive communication/escalation of data management issues and risks.
Development and maintenance of program level DM deliverable timelines in accordance with program development strategy; drive internal and external timeline negotiations.
Management of data management vendors providing consistent team direction/guidance and monitoring quality of work through vendor audits and key performance metrics.
Facilitate and perform cross-functional sponsor review meetings of eCRF design, edit check specifications and user acceptance testing.
Facilitate the development of data transfer agreements with external data vendors (e.g., clinical laboratories, imaging vendors) ensuring data quality from data capture to reporting.
Perform sponsor review of DM essential documents including annotated CRFs, eCRF Completion Guidelines, Clinical Data Management Plans and DB Go Live and Lock documentation.
Contribute to the development, review and revision of department processes (e.g., SOPs, job aids, standards/templates) to improve quality, effectiveness and efficiency.

Bachelor’s degree or higher in the scientific, biological, statistical or computer science field or related discipline.
5 plus years’ experience in Data Management in a pharmaceutical R&D or CRO
Ability to create strong, collaborative working relationships. Demonstrate excellent verbal/written and interpersonal skills required to effectively communicate and collaborate in a cross-functional team environment.
Working knowledge of common Data Management applications (e.g. database programs and programming / query languages); Oracle Inform database development experience a plus.
General knowledge of industry standards and best practices (e.g., CDISC/CDASH, SCDM GCDMP).
Practical knowledge of GCP regulations and guidelines
Familiarity with handling lab/image data from external data sources
Ability to manage competing priorities and anticipate and escalate issues in a timely manner.
Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, Project and Outlook).
Strong attention to detail, planning and organizational skills