About this Senior Manager, Clinical Data Management role at Ultragenyx Pharmaceutical
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:
- 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.
Requirements:
- Bachelor’s degree or higher in the scientific, biological, statistical, or computer science field or related discipline.
- Minimum 5-8 years of clinical trial data management experience in the pharma/biotech industry.
- Strong experience in CRO, FSP and vendor management with consistent track record of on-time quality deliverables.
- Extensive technical experience using electronic data capture systems.
- 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.
#LI-CS1 #LI-Remote
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
