Senior Manager, Clinical Data Management

Role Description

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.

Qualifications

• 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.

Requirements

• 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.
• Benefits vary by region and country.