Principal Database Programmer

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

📋 Description

• Oversee all programming facets of clinical databases and applications from the initiation of the study until after the database is locked.

• Direct operational study teams and programming personnel for designated studies and study programs.

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

• Provide planning estimates regarding project scope, timelines, forecasting, and resource necessities.

• Manage assigned projects to ensure timely delivery.

• Update internal teams and study/project teams on project status, contract scope, and work progress.

• Anticipate project hours, determine resource needs, and oversee project budgets, out-of-scope work, and post-production modifications.

• Offer insights and recommendations on clinical database design to clients and internal teams.

• Construct, enhance, test, validate, maintain, and support clinical databases, programs, internal applications, and third-party applications.

• Deliver system administration and advanced technical assistance.

• Diagnose and resolve software and clinical database issues.

• Create and uphold study-specific validation documentation.

• Aid in data management from CRF design through post-database closure and archival processes.

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

• Assist in the onboarding process for new employees.

• Provide leadership for cross-functional and organization-wide initiatives.

• Liaise with study sponsors, vendors, and project teams concerning data, database, and project-related matters.

• Conduct software demonstrations, trainings, departmental/company training sessions, and project meetings.

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

• Undertake other assigned responsibilities.

⛳️ Requirements

• A minimum of 8 years of experience.

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

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

• Strong expertise in Rave and Veeva.

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

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

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

• Proficiency in multiple CDMS systems, including form building, edit checks, and complex rule development.

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

• Capability to troubleshoot and assist colleagues with technical issues and develop solutions.

• Comprehensive understanding of drug, device, and/or biologic development and effective data management practices.

• Competent in handling a variety of clinical research tasks.

• Exceptional organizational and communication abilities.

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

• Experience in the development of clinical database management systems.

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

• Strong leadership and interpersonal abilities.

• Preferred: experience in multiple therapeutic areas.

• Preferred: familiarity with various Database Programming systems.

• Preferred: ability to work independently, manage time effectively, and formulate plans to achieve project revenue and business objectives.

• Preferred: capability to operate efficiently with minimal supervision.

• Preferred: team collaboration and knowledge sharing skills.

• Preferred: highly organized with effective communication, interpersonal and negotiation skills, along with excellent organization and prioritization skills.

• Preferred: customer service orientation and experience in client relationship management.

🏝️ Benefits

• Full-time, permanent position.

• Fully remote work available from European locations.

• May require occasional travel.