Principal Database Programmer
Precision Medicine Group2 hours ago
Responsibilities
- Manage programming activities for clinical databases and applications from study start through post-database lock.
- Build, develop, test, validate, maintain, troubleshoot, and support clinical databases and related applications.
- Lead operational study teams and programming team members on assigned studies and programs.
- Provide advanced technical support and system administration for clinical databases and internally developed or third-party applications.
- Provide database design guidance, support data management from CRF design through archival, and maintain study-specific validation documentation.
- Forecast project hours, schedules, timelines, resource requirements, budgets, scope changes, and post-production work.
- Communicate project status and technical issues with internal teams, clients, sponsors, EDC vendors, third-party vendors, and project teams.
- Deliver software demonstrations, technical training, onboarding support, and training for data management project members and end users.
- Contribute to software vendor selection, SOPs, process documentation, and cross-functional or organization-wide initiatives.
- Perform work according to SOPs, government regulations, guidelines, and industry standards; some travel may be required.
Requirements
- At least 8 years of experience.
- Bachelor’s degree and/or a combination of related experience.
- Strong oncology experience; autoimmune disease experience is an advantage.
- Strong experience with Rave and Veeva.
- Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
- Experience with object-oriented programming such as C#, C++, or VBS.
- Understanding of CDISC standards, including CDASH, SDTM, and ADaM.
- Proficiency in more than one clinical database management system, including form building, edit checks, and complex rule development.
- Experience with clinical database management system development and a clinical, scientific, or healthcare discipline.
- Broad knowledge of drug, device, or biologic development and effective data management practices.
- Ability to troubleshoot technical issues, build solutions, handle varied clinical research tasks, and work with CRF standards and standards libraries.
- Strong leadership, organizational, communication, interpersonal, negotiation, prioritization, and client relationship management skills.
- Preferred qualifications include experience across multiple therapeutic areas, various database programming systems, independent project and business planning, and successful client relationship management.
Benefits
- Full-time, permanent position.
- Fully remote work from European locations.
- Some travel may be required.
About Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.