Director, Clinical Data Management

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

The Director, Clinical Data Management position provides data management oversight and support to project teams on all data management matters, including optimizing overall performance, generic systems and procedures.  This position will collaborate cross-functionally to lead program deliverables to support program objectives.  This role is accountable for the quality and timely completion of project deliverables and responsible for multiple or broad areas of significant impact. 

This Director CDM position is accountable for strategy and functional management across assigned critical programs through a combination of resourcing, including, contingent workers, department collaboration and individual contributions.  This position is responsible for ensuring successful achievement of individual goals, as well as other department project goals and objectives. 

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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:

• Leads data management efforts within assigned key company programs
• Collaborates with cross-functional leads to meet program deliverables, timelines to support program objectives and deliverables 
• Identification and leadership of critical DM process improvement initiatives 
• Identification, evaluation and selection of DM vendors and establishment and management of key vendor partnerships 
• Lead vendor qualification and oversight audits as DM SME, as needed 
• Ensure compliance with regulatory and industry process and quality standards and program compliance with regulatory and industry process and quality standards and representation of function in regulatory inspections  
• Collaboration with cross-functional leads to ensure program teams’ effectiveness and success 
• Proactively identifies potential study or process issues/risks and spearheads solutions 
• Provides Leadership/Oversight to ensure high quality CDM deliverables and study-related documents (e.g., eCRF and edit check requirements, Clinical Data Management Plan, CRF Completion Guidelines) to program teams 
• Participates in the selection, training and evaluation of DM personnel (internal and contract) to ensure efficient and effective department function 

Requirements:

• Bachelor’s degree required; advanced degree preferred in the scientific, biological, statistical or computer science field or related discipline 
• Minimum 10 years of experience in the pharma/biotech industry with a minimum of 8 years’ vendor management experience  
• Vendor evaluation, selection and management experience with experience managing data management activities outsourced to Clinical Research Organizations, Functional Service Providers and other vendors  
• Ability to build and maintain positive relationships with management, peers and direct reports