Senior Manager, Clinical Data Management
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are located in Novato, CA, 25 miles north of San Francisco and an office in Brisbane.
Reporting to the Head of Data Management, the Senior Manager of Data Management is accountable for the overall success of Data Management for his/her program. 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
Responsibilities including, but not limited to:
- Operational leadership of data management activities for one or more programs.
- Management of data management vendors providing consistent team direction/guidance and monitoring quality of work through vendor audits and key performance metrics.
- Development and maintenance of program level DM deliverable timelines in accordance with program development strategy. Actively drives internal and external timeline negotiations, as needed.
- Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks.
- Facilitate cross-functional sponsor review meetings of eCRF design and edit check specifications.
- Facilitate and perform cross-functional sponsor EDC user acceptance testing.
- Facilitate the development of data transfer agreements with central/specialty labs and other external data vendors. Ensuring data quality from data capture to reporting.
- Facilitate the development and implementation of key data and metrics reports/listings.
- Perform sponsor review of DM essential documents including annotated CRFs, eCRF Completion Guidelines, Data Management Plans and DB Go Live and Lock documentation.
- Contribute to Data Management department infrastructure, by leading/contributing to SOPs development, CRF standards development and cross-functional process improvement initiatives.
- Contribute to development of DM outsourcing strategy through the identification, evaluation and selection of key CRO partnerships.
- Contribute to the evaluation, selection and implementation of novel electronic data capture solutions
- Bachelor’s degree or higher in the scientific, biological, statistical or computer science field or related discipline
- Minimum 4-6 years of clinical trial data management experience in the pharma/biotech industry
- Strong experience in CRO and vendor management with consistent track record of on-time quality deliverables
- Extensive technical experience using electronic data capture systems. EDC database development experience a plus
- In-depth knowledge of DM industry standards, best practices and CDISC/CDASH implementation
- Ability to adapt and manage competing and rapidly changing priorities
- Effective in proactively identifying issues and driving team towards creative solutions and smart decisions
- 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
- Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, Project and Outlook)
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.