Director, Clinical Data Management
Ultragenyx Pharmaceutical Inc.
Position Summary:
The Director, Clinical Data Management position provides data management oversight and support to project teams on all data management matters, including optimizing overall performance, generic systems and procedures. This position will collaborate cross-functionally to lead program deliverables to support program objectives. This role is accountable for the quality and timely completion of project deliverables and responsible for multiple or broad areas of significant impact.
This Director CDM position is accountable for strategy and functional management across assigned critical programs through a combination of resourcing, including, contingent workers, department collaboration and individual contributions. This position is responsible for ensuring successful achievement of individual goals, as well as other department project goals and objectives.
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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:
- Leads data management efforts within assigned key company programs
- Collaborates with cross-functional leads to meet program deliverables, timelines to support program objectives and deliverables
- Identification and leadership of critical DM process improvement initiatives
- Identification, evaluation and selection of DM vendors and establishment and management of key vendor partnerships
- Lead vendor qualification and oversight audits as DM SME, as needed
- Ensure compliance with regulatory and industry process and quality standards and program compliance with regulatory and industry process and quality standards and representation of function in regulatory inspections
- Collaboration with cross-functional leads to ensure program teams’ effectiveness and success
- Proactively identifies potential study or process issues/risks and spearheads solutions
- Provides Leadership/Oversight to ensure high quality CDM deliverables and study-related documents (e.g., eCRF and edit check requirements, Clinical Data Management Plan, CRF Completion Guidelines) to program teams
- Participates in the selection, training and evaluation of DM personnel (internal and contract) to ensure efficient and effective department function
Requirements:
- Bachelor’s degree required; advanced degree preferred in the scientific, biological, statistical or computer science field or related discipline
- Minimum 10 years of experience in the pharma/biotech industry with a minimum of 8 years’ vendor management experience
- Vendor evaluation, selection and management experience with experience managing data management activities outsourced to Clinical Research Organizations, Functional Service Providers and other vendors
- Ability to build and maintain positive relationships with management, peers and direct reports
- Required experience in NDA/BLA/MAA and regulatory submissions and direct interactions with global regulatory authorities; practical knowledge of FDA regulations/ ICH guidelines, as related to data integrity
- Experience with multiple Electronic Data Capture (EDC) systems, including Oracle Inform, and working with vendor programming services
- Knowledge of CDISC, including CDASH and controlled terminologies
- Self-directed, technically strong, and a recognized leader maintaining a strategic prospective regarding data management processes, management of DM activities and customer management
- Knowledge of lab/image data and other external data sources
- Strong understanding of clinical trials, pharmaceutical operations, and regulatory compliance
- Ability to manage time demands, incomplete information and unexpected events
- Excellent communication and interpersonal skills; strong analytical and problem-solving skills and attention to detail
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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.