Manager, DMP Data Management

Location
Novato, CA (Remote)
Posted
Jul 31, 2018
Discipline
Clinical, Clinical Data
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Why Join Us?

To be a hero for our rare disease patients

Ultragenyx is a biopharmaceutical company committed to bringing to patients novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy 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. 

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.

Come join our team during this exciting time of growth and opportunities!

Position Summary

ultracurious – Apply your biggest ideas in courageous ways

The Manager, DMP Data Management is responsible for managing the clinical trial data for one or more assigned DMP projects and serves as a liaison between Ultragenyx and assigned vendors to implement and maintain the clinical databases, while delivering the required technology solutions for the Disease Monitoring Programs (DMP).

The successful candidate will lead all data management aspects for the DMP Program, for the molecule assigned.  The DMPs are signature initiatives with high visibility both within the company and, as they progress, outside the company.  The DMPs are designed to be innovative, cutting edge research studies combining both in-clinic natural history assessments and on-line patient reported experiences over a 10+ year time period.  The DMPs will be the main data generation initiatives supporting our products through their life cycle.  The main objectives of the DMPs are to gather longitudinal real-world safety and effectiveness data; address post-marketing commitments; identify patients; and expand knowledge of the clinical presentation, progression and variation of the disease for both internal and external uses (data sharing).

The ideal candidate will not only have deep data management experience, but also a solid understanding of the cross functional activities of the traditional development stakeholders, both upstream and downstream to the DM deliverables.

Insight about global requirements for clinical trial execution, data sharing, data warehousing, mobile health, patient privacy, as well as rare disease drug development and an understanding of longitudinal cohort studies, is a plus.  The individual will be a self-starter with excellent leadership skills, strong focus on innovation, and most importantly, collaboration

Responsibilities including, but not limited to:

  • Represent DMP data management at cross functional team meetings, providing accurate study status updates and proactive communication/escalation of data management issues and risks
  • Design, or direct the design of, a Case Report Form (CRF) for data collection
  • Develop, or direct the development of, a Data Management Plan (DMP), outlining all data management responsibilities
  • Design, or direct the design of, an efficient logical database using Ultragenyx standards, which can be exported efficiently into SAS
  • Ensure logical edit checks are defined and validated for data quality control
  • Work in collaboration with contracted vendor(s) to coordinate activities such as medical coding, electronic data transfer, and other aspects of data clean-up
  • Respond to inquiries and provide guidance to study team to ensure accuracy of data
  • Ensure completion of a comprehensive data review
  • Verify, or supervise verification of, query resolutions and data clarifications
  • Communicate with the DMP team as needed regarding data/database issues
  • Produce reports, listings, metrics and other output as required during the course of the project
  • Facilitate the development of data transfer agreements with central/specialty labs and other external data vendors. Ensure data quality from data capture through reporting.
  • Facilitate the development and implementation of key data and metrics reports/listings
  • Perform, or assist in, the validation of clinical study databases, including the validation efforts within IT for new vendor evaluation and implementation
  • Collaborate with clinical data management to ensure alignment on specific standard company policies and operating procedures and to share best practices within Ultragenyx

Technical Requirements & Skills:

  • Minimum 7 years in biotech / pharmaceutical industry 
  • Experience in disease monitoring programs with the implementation and management of virtual/remote direct to patient studies is preferred
  • Proven leadership and project management skills, and the ability to bring out the best in others on a cross-functional global team. 
  • Must be analytical and articulate in both oral and in writing skills, with a demonstrated ability to communicate well with others at varying professional levels, especially in the technical aspects of clinical systems.
  • Track record of forming compliant partnerships with colleagues and external vendors
  • Ability to think creatively, and efficiently to define problems, collect data, establish facts and draw valid conclusions

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.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will  not create any implied obligation.  Inquiries on developing a recruiting relationship with us, may be directed tohr@ultragenyx.com.