Senior Manager, Clinical Data Management

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Manager of Data Management is accountable for the overall Data Management success for his/her Disease Monitoring Program (DMP) clinical studies. 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. 

This position is responsible for ensuring achievement of his/her own goals as well as other departments and project goals and objectives. The position may have line management responsibilities and will continue to perform hands-on activities. 

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:

1. Management of data management vendors providing consistent team direction/guidance and monitoring quality of work through vendor audits and key performance metrics. 
2. Development and maintenance of program level DM deliverable timelines in accordance with program development strategy. Actively drives internal and external timeline negotiations, as needed. 
3. Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks. 
4. Facilitate cross-functional sponsor review meetings of eCRF design and edit check specifications. 
5. Facilitate and perform cross-functional sponsor EDC user acceptance testing. 
6. Facilitate the development of data transfer agreements with central/specialty labs and other external data vendors. Ensuring data quality from data capture to reporting. 
7. Facilitate the development and implementation of key data and metrics reports/listings. 
8. Perform sponsor review of DM essential documents including annotated CRFs, eCRF Completion Guidelines, Data Management Plans and DB Go Live and Lock documentation. 

Requirements:

1. Bachelor’s degree or higher in the scientific, biological, statistical, or computer science field or related discipline. 
2. Minimum 5-8 years of clinical trial data management experience in the pharma/biotech industry. 
3. Strong experience in CRO, FSP and vendor management with consistent track record of on-time quality deliverables. 
4. Extensive technical experience using electronic data capture systems. 
5. In-depth knowledge of DM industry standards, best practices, and CDISC/CDASH implementation. 
6. Ability to adapt and manage competing and rapidly changing priorities. 
7. Effective in proactively identifying issues and driving team towards creative solutions and smart decisions. 

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