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Ultragenyx

Rare mission. Fearless team. Incredible possibilities.

Senior Manager, Clinical Data Management

Data ScientistData ScientistFull TimeRemoteSeniorTeam 501-1,000Since 2010H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

15 hours ago

Salary

$178.7K - $220.7K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglishGo

Job Description

Senior Manager, Clinical Data Management

Ultragenyx

• 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.

Job 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.

Benefits

  • Generous vacation time and public holidays observed by the company
  • Volunteer days
  • Long term incentive and Employee stock purchase plans or equivalent offerings
  • Employee wellbeing benefits
  • Fitness reimbursement
  • Tuition sponsoring
  • Professional development plans

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