Principal Database Programmer

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Oversee all programming elements of clinical databases and applications from the initiation of studies until after database lock.

• Direct operational study teams and programming members on designated studies and study initiatives.

• Deliver operational and technical training to end users, junior personnel, and data management project team members.

• Offer planning estimates regarding project scope, schedules/timelines, forecasting, and resource needs.

• Hold accountability for assigned projects and guarantee timely delivery.

• Communicate project status, contract scope, and updates on work to internal teams and study/project groups.

• Anticipate hours, pinpoint resource requirements, and oversee project budgets, out-of-scope tasks, and post-production modifications.

• Contribute insights and guidance on clinical database design.

• Construct, develop, test, validate, maintain, and support clinical databases, internally created applications, client projects, and third-party applications.

• Provide system administration and advanced technical assistance.

• Diagnose and resolve software and clinical database issues.

• Create and maintain study-specific validation documents.

• Assist with data management from CRF design through database closure and archival processes.

• Engage in software vendor selection, EDC demonstrations, training sessions, SOP development, and process documentation.

• Aid in the onboarding of new hires and provide leadership for cross-functional and organization-wide initiatives.

• Liaise with study sponsors, vendors, clients, and project teams regarding project challenges.

• Conduct software demonstrations, training sessions, and project meetings.

• Execute duties in accordance with SOPs, government regulations, guidelines, and industry standards.

• Undertake additional assigned responsibilities; occasional travel may be necessary.

⛳️ Requirements

• A minimum of 8 years of relevant experience.

• Bachelor's degree and/or a combination of related experience.

• Extensive experience in Oncology; familiarity with Autoimmune diseases is a significant advantage.

• Strong expertise with Rave and Veeva.

• Proficient in Microsoft Office: Word, Excel, PowerPoint, and Outlook.

• Experience in Object-Oriented Programming (C#, C++, VBS, etc.).

• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).

• Proficient in multiple CDMS systems, including the creation of forms, edit checks, and complex rule development.

• Awareness of CRF standards and contribution to the maintenance of the standards library.

• Capability to troubleshoot and assist peers with technical issues while developing solutions.

• Broad knowledge of drug, device, and/or biologic development along with effective data management practices.

• Competent in managing a variety of clinical research tasks.

• Exceptional organizational and communication skills.

• Professional proficiency in the English language, both written and spoken.

• Experience in clinical database management system development.

• Background in a clinical, scientific, or healthcare discipline.

• Strong leadership and interpersonal capabilities.

• Preferred/optional: experience across multiple therapeutic areas; familiarity with various Database Programming systems; ability to work independently and manage time effectively; self-motivated and self-directed; collaboration and knowledge sharing; strong organization, communication, negotiation, prioritization, customer service, and client relationship management skills.

🏝️ Benefits

• Full-time, permanent position.

• Completely remote work from European locations.

• May involve some travel.