Commercial Director, Education / Learnerships / Admissions
Hyperion Development, LLC
JavaPython
Director, Clinical Data Management
Ultragenyx
full-time
Posted on:
Location Type: Hybrid
Location: 🇺🇸 United States
Visit company websiteSalary
💰 $199,100 - $245,900 per year
Job Level
Lead
Tech Stack
Oracle
About the role
- Provides data management oversight and support to project teams on all data management matters, including optimizing overall performance, generic systems and procedures
- Collaborates cross-functionally to lead program deliverables to support program objectives
- Accountable for the quality and timely completion of project deliverables and responsible for multiple or broad areas of significant impact
- Accountable for strategy and functional management across assigned critical programs through resourcing (including contingent workers) and individual contributions
- Leads data management efforts within assigned key company programs
- Identifies and leads critical DM process improvement initiatives
- Identifies, evaluates and selects DM vendors; establishes and manages key vendor partnerships
- Leads vendor qualification and oversight audits as DM SME as needed
- Ensures compliance with regulatory and industry process and quality standards and represents the function in regulatory inspections
- 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)
- 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
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
- Eligible for annual bonus and equity incentives
- Remote work (officially documented as working full-time from home)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data managementvendor managementElectronic Data Capture (EDC)Oracle InformCDISCCDASHdata integrityclinical data managementregulatory submissionsstatistical analysis
Soft skills
leadershipcommunicationinterpersonal skillsanalytical skillsproblem-solvingattention to detailrelationship buildingtime managementstrategic thinkingself-direction
