Principal Database Programmer
Precision Medicine Group2 hours ago
Responsibilities
- Manage clinical database programming activities from study start through post-database lock for assigned projects.
- Build, develop, test, validate, maintain, and support clinical databases, internal applications, and third-party applications.
- Provide system administration, advanced technical support, troubleshooting, and resolution of software and clinical database problems.
- Lead operational study teams and programming team members on assigned studies and programs.
- Provide project forecasting, resource planning, timeline estimates, budget management, and out-of-scope work identification.
- Provide guidance on clinical database design and support data management from CRF design through database close and archival.
- Develop and maintain study-specific validation documents, SOPs, and related process documentation.
- Deliver technical training, software demonstrations, onboarding, and support for end users, junior staff, and data management team members.
- Communicate with clients, study sponsors, vendors, project teams, data management, project management, and other external and internal stakeholders.
- Participate in software vendor selection and cross-functional or organization-wide initiatives.
- Perform duties according to SOPs, government regulations, guidelines, and industry standards.
- 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 advantageous.
- 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 CDMS system, including building forms, edit checks, and complex rules.
- Experience with clinical database management system development.
- Experience in a clinical, scientific, or healthcare discipline is required or preferred, including multiple therapeutic areas as a preferred qualification.
- Broad knowledge of drug, device, or biologic development and effective data management practices.
- Ability to troubleshoot technical issues, develop solutions, manage clinical research tasks, work independently, and plan toward project and business goals.
- Strong leadership, communication, organizational, prioritization, interpersonal, negotiation, and client relationship management skills.
- Professional written and spoken English.
- Experience with various database programming systems is preferred.
Benefits
- Full-time, permanent position.
- Fully remote work from European locations.
- May require some travel.
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.