Associate Director/Director, Data Management
$160,000–$230,000 year
Remote · San Diego, California, United States
Job Summary
Lead data management for clinical studies overseeing EDC vendor oversight, database startup through database lock, data management documentation, data metrics reporting, and data cleaning activities. Act as the DM lead for one or more studies, establish partnerships with DM vendors, ensure clinical databases and external data files are designed to standard, accurate, complete, and analysis-ready for regulatory submission. Oversee vendor performance, review study documents, protocols, and data for accuracy; coordinate data reviews (TLF analysis, patient profiles); ensure audit-ready documentation and regulatory readiness; oversee database development and maintenance per ICH/GCP; collaborate with statistics and programming for high-quality data outputs; develop and report data management performance metrics; support IND/NDA submissions as appropriate; travel up to 20%.
Required Qualifications
- Bachelor’s Degree required
- Minimum 10 years of clinical data management experience in biotechnology or pharmaceutical industry required
- Advanced knowledge of data management processes and systems
- Advanced knowledge of setting up Clinical Databases in Medidata Rave
- Solid understanding of clinical drug development processes
- Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills
- Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment
- Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities
- Excellent organizational skills with the ability to manage staff, projects, resources, timelines, and budgets
- Travel requirements include travel domestically and/or internationally up to 20%
- The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.
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