Senior Manager, Clinical Data Management - Novato, CA | Biospace
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Senior Manager, Clinical Data Management

Ultragenyx Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
7/20/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Clinical Data Management,

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 with additional office space in Brisbane, CA.

Position Summary:

This is an exciting opportunity to join an emerging biotechnology company focused on developing therapeutics for patients with rare diseases.

Reporting to the Senior Manager, Data Management, the ideal candidate is a dynamic data manager who thrives in a fast paced environment and is looking for a unique opportunity to develop a multi-dimensional and well-rounded Data Management skill set with possible exposure to database development, SOP development and vendor management.

Responsibilities, including but not limited to:

•   Act as Lead Data Manager for 2-3 studies, lead Data Management Study Start-Up including the development and review of Case Report Forms, edit check specifications, eCRF completion guidelines and Data Management Plans/Data Review Strategy and the execution and documentation of Sponsor User Acceptance Testing.
•   Vendor management of Data Management service provider for assigned outsourced studies.
•   Develop, maintain and manage DM deliverables timeline for assigned projects.
•   Develop and maintain data transfer agreements with External Data Vendors.  Manage data transfers for assigned clinical studies.
•   Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication of data management risks.
•   Participate in the development of department SOPs and standards/templates with focus on CDISC/CDASH implementation.

Requirements

•   Bachelor’s degree or higher in the scientific, biological, statistical or computer science field or related discipline.
•   At least seven years of clinical trial data management experience in the pharma/biotech industry.
•   Experience in the execution of a complete DM study cycle (Start-Up, Conduct, Close-Out) a plus.  
•   Data management experience using EDC systems such as BioClinica or Medidata.
•   Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, Project and Outlook). MS Project experience preferred.
•   General knowledge of industry standards and best practices such as CDISC/CDASH data standardization.
•   Ability to manage competing priorities and anticipate and escalate issues in a timely manner.
•   Proven track record of on-time and high quality Data Management deliverables.
•   Excellent communication and interpersonal skills.

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.