Manager, Clinical Systems - Novato, CA | Biospace
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Manager, Clinical Systems

Ultragenyx Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
5/24/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Operations, Manager,

Job Description

Why Join Us?

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 headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco.

Position Summary:

The Manager of Clinical Systems is responsible for supporting the lifecycle management of clinical systems for Clinical Operations, with a focus on the Interactive Response Technology (IRT) systems.  This position can also provide systems support for other clinical systems, such as Clinical Trial Management System (CTMS) and eTMF.  The Manager of Clinical Systems has a high degree of expertise and practical experience in clinical trial management and clinical systems.  The core duties and responsibilities of this position include, but are not limited to:

Responsibilities:
•   Lead cross-functional teams, such as the IRT Core Team, through planning, design, configuration and deployment of new clinical systems and enhancements to existing applications. Includes coordinating and participating in system requirements, development, user acceptance testing and system enhancements, as necessary
•   Partner with IT, Quality Systems and Clinical Operations stakeholders on all clinical system integrations and upgrades
•   Support the Clinical Operations team in managing the IRT vendor relationship on a day-to-day basis to ensure optimum system performance and to address/escalate issues, as appropriate
•   Develop Standard Operating Procedures (SOPs) and guidelines related to the management and use of clinical systems
•   Provide training on IRT and other clinical systems, as necessary
•   Act as a change agent to ensure minimal organizational disruption during new system/process implementation
•   Support administration activities of clinical systems (e.g., User Management)
•   Partner with internal teams to analyze IRT and vendor performance to ensure compliance against contracted services
•   Support end users as an internal IRT Subject Matter Expert
•   Oversee governance for IRT and other clinical systems, as applicable
•   Evaluate new technologies, as appropriate

Requirements

•   Bachelor degree or equivalent required (scientific or technical discipline preferred)
•   3-5 years of clinical systems experience (IRT, CTMS, eTMF, etc.)
•   PC literacy required; common MS application skills SharePoint, Outlook, Word, Excel, PowerPoint, Visio
•   Experience or good knowledge with databases and reports
•   Detailed understanding of clinical trial operations and regulations (Good Clinical Practice, 21 CFR Part 11)
•   Experience with or understanding of clinical trial related documentation
•   Ability to lead cross-functional teams and change initiatives through implementation with little or no oversight
•   Experience in developing business specifications/requirements and user acceptance testing for computer systems

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.