Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Manager of Clinical Data Management is accountable for the overall success of Data Management for their program(s). The ideal candidate is a dynamic, driven and decisive data management professional who is a self-starter, thrives in a fast-paced environment and is looking for the rare and exciting opportunity to have a significant foundational impact on a growing data management department.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• 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. Drives internal and external timeline negotiations, as needed.
• 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.

Requirements:

• 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 #LI-CS1 #LI-Remote