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SalaryPosition Summary:
ultrafocused – Work together to fearlessly uncover new possibilities
The Associate Director (AD) of Clinical Data Management (CDM) will provide leadership and support the Ultragenyx Clinical Data Management (CDM) activities. The Associate Director will leverage their experience within standards development and implementation, strategic resourcing, timeline planning, vendor management, as well as technology evaluation and selection. Additionally, this position involves process development and implementation that requires coordination of activities with other cross-functional groups to ensure timeliness and quality of project deliverables. The Associate Director will also oversee outsourced Data Management vendor/systems and will be responsible for oversight of CRO/FSP Data Management and ensure data compliance accordance with ICH/GCP.
This position is responsible for ensuring achievement of his/her own goals as well as other department and project goals and objectives. The position may have line management responsibilities and will continue to have 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:
- Lead assigned studies and provide continuous support from database set-up through lock.
- Ensure appropriate resources to meet the demands of the clinical studies
- Lead the Clinical Data Management plan, including timeline, budget, and resources
- Lead the EDC design process and review database specifications, eCRF completion guidelines and data validation specifications in collaboration with cross functional groups.
- Prepare and/or review/approve study-related documents (e.g., Clinical Data Management Plan, eCRF Completion Guidelines, Data Transfer Agreements, Data Validation Specifications)
- Manage EDC User Acceptance Testing (UAT) activities
- Oversee and/or manage of all data review activities
- Manage data transfers and ensure quality of all delivered data
- Proactively identify potential study issues/risks and recommend/implement solutions
- Ensure program compliance with regulatory and industry process and quality standards
- Prepare metrics and updates for management
- Collaboration with cross-functional leads to ensure team effectiveness
- Actively participate in the development and review of department process documents (e.g., SOPs, guidelines, templates)
- Direct report management and mentorship, as applicable
- Participate in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
- Manage and coordinate the activities of internal teams and vendors.
- Manage contracted CROs/FSPs on outsourced Data Management process including managing timelines and tracking deliverables
Requirements:
- Bachelor's degree or higher in the scientific, biological, statistical or computer science field or related discipline
- 10+ years of experience in Clinical Data Management with increasing responsibilities and managerial/leadership duties
- Vendor evaluation, selection and management experience
- Experience in managing direct reports and multiple programs
- Experience with multiple Electronic Data Capture (EDC) systems, including Oracle InForm, and working with vendor programming services
- Experience and in-depth knowledge in CDISC, including CDASH, SDTM, ADaM, and controlled terminologies
- Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to Data Management processes, management of DM activities and customer management
- Experience managing Data Management activities outsourced to Clinical Research Organizations, Functional Service Providers, and other vendors
- Knowledge of lab/image data and other external data sources
- Strong understanding of clinical trials and regulatory compliance
- Practical knowledge of FDA regulations/ICH guidelines, as related to data integrity
- Ability to manage time demands, incomplete information and unexpected events
- Ability to build and maintain positive relationships with management, peers, cross-functional team members and direct reports
- Excellent communication and interpersonal skills
- Strong analytical and problem solving skills. Attention to detail.
- Ability and willingness to travel <20% of the time #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.
Pay Range
- 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
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.
