Principal Database Programmer
Precision Medicine Group2 hours ago
Responsibilities
- Manage all programming aspects of assigned clinical databases and applications from study start through post-database lock.
- Build, develop, test, validate, maintain, troubleshoot, and support clinical databases, internally developed applications, and third-party applications.
- Lead operational study teams and programming team members on assigned studies and programs.
- Provide project forecasting, resource planning, timeline estimates, budget management, and scope monitoring.
- Provide database design guidance and support data management from CRF design through database close and archival.
- Develop and maintain study-specific validation documents, SOPs, and process documentation.
- Provide technical support, user training, software demonstrations, onboarding support, and training for data management team members.
- Communicate with clients, sponsors, vendors, project teams, and internal departments regarding requirements, status, and project issues.
- Participate in vendor selection and cross-functional or organization-wide initiatives.
- Perform duties in accordance with SOPs, regulations, guidelines, and industry standards; some travel may be required.
Requirements
- At least 8 years of experience is required.
- A bachelor’s degree and/or a combination of related experience is required.
- Strong oncology experience is required; autoimmune disease experience is an advantage.
- Strong experience with Rave and Veeva is required.
- Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Outlook, is required.
- Experience with object-oriented programming such as C#, C++, or VBS is required.
- Understanding of CDISC standards, including CDASH, SDTM, and ADaM, is required.
- Experience with more than one CDMS, including building forms, edit checks, and complex rules, is required.
- Experience in clinical database management system development and in a clinical, scientific, or healthcare discipline is required or preferred.
- Knowledge of drug, device, or biologic development and data management practices is required.
- Strong leadership, organizational, communication, interpersonal, prioritization, and client relationship management skills are required.
- Preferred qualifications include experience across multiple therapeutic areas, various database programming systems, independent project planning, negotiation, customer service, and working with minimal direction.
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.