Associate Director, Clinical Data Management

at  Ultragenyx Pharmaceutical

WHY JOIN US?

Be a hero for our rare disease patients
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

POSITION 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.

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.

• 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